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Data / Medical devices / United States / ACRO BIOTECH Inc.

ACRO BIOTECH Inc.: FDA-registered device maker in Montclair, CA, United States, 31 510(k) clearances

ACRO BIOTECH Inc. is registered with the FDA (registration 3005360469) in Montclair, CA, United States. It lists 138 device types. The FDA files 31 510(k) clearances under its listings, the newest dated October 30, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch ACRO BIOTECH Inc.
FDA registration number
3005360469
FEI number
3005670738
Address
4650 Arrow Hwy Suite D6, Montclair, CA, United States, 91763
Owner or operator
Acro Biotech Inc. (10043465)
Roles
Repackager or relabeler
First device listed
February 19, 2013
Registered through
2027
Brand names listed
6-Monoacetylmorphine (6-MAM) Rapid Test Midstream Oral Fluid, 6-Monoacetylmorphine (6-MAM) Rapid Test Cassette Oral Fluid, 6-Monoacetylmorphine (6-MAM) Rapid Test Cassette Urine, 6-Monoacetylmorphine (6-MAM)Rapid Test Panel Powder, 6-Monoacetylmorphine (6-MAM)Rapid Test Panel Urine, 6-Monoacetylmorphine(6-MAM) Rapid Test Dipstick Urine, ?-Pyrrolidinovalerophenone (?-PVP ) Rapid Test Cassette Oral Fluid, ?-Pyrrolidinovalerophenone (?-PVP ) Rapid Test Cassette Urine and more

Devices it lists

DeviceProduct codeClassRoleSource
Abnormal Hemoglobin QuantitationGKA2Repackager or relabeleraccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Repackager or relabeleraccessdata.fda.gov
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodDIC2Repackager or relabeleraccessdata.fda.gov
Antibody Igm,If, Cytomegalovirus VirusLKQ2Repackager or relabeleraccessdata.fda.gov
Antibody, Monoclonal Blocking, Hiv-1MVXNRepackager or relabeleraccessdata.fda.gov
Antigen, Cf (Including Cf Control), Epstein-Barr VirusGNQ1Repackager or relabeleraccessdata.fda.gov
Antigen, Ebv, CapsidMCD1Repackager or relabeleraccessdata.fda.gov
Antigen, Id, Candida AlbicansLHK2Repackager or relabeleraccessdata.fda.gov
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.KHW2Repackager or relabeleraccessdata.fda.gov
Antigen, Treponema Pallidum For Fta-Abs TestJWL2Repackager or relabeleraccessdata.fda.gov
Antigens (Febrile), Agglutination, Brucella Spp.GSO2Repackager or relabeleraccessdata.fda.gov
Antigens, All Groups, Salmonella Spp.GRL2Repackager or relabeleraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Repackager or relabeleraccessdata.fda.gov
Antigens, All Types, Escherichia ColiGMZ1Repackager or relabeleraccessdata.fda.gov
Antigens, All, Leptospira Spp.GRY2Repackager or relabeleraccessdata.fda.gov
Antigens, Cf (Including Cf Control), Adenovirus 1-33GOD1Repackager or relabeleraccessdata.fda.gov
Antigens, Cf, All, Mycoplasma Spp.GSB1Repackager or relabeleraccessdata.fda.gov
Antiserum, Fluorescent, Mycobacterium TuberculosisGRT1Repackager or relabeleraccessdata.fda.gov
Antiserum, Vibrio Cholerae, All VarietiesGSQ2Repackager or relabeleraccessdata.fda.gov
ApolipoproteinsMSJ1Repackager or relabeleraccessdata.fda.gov
Assay, Genotyping, Hepatitis C VirusOBF2Repackager or relabeleraccessdata.fda.gov
Automated Urinalysis SystemKQO1Repackager or relabeleraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Repackager or relabeleraccessdata.fda.gov
Biosensor, Immunoassay, MyoglobinMVE2Repackager or relabeleraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Repackager or relabeleraccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Repackager or relabeleraccessdata.fda.gov
Calprotectin, FecalNXO2Repackager or relabeleraccessdata.fda.gov
Campylobacter Spp.LQP1Repackager or relabeleraccessdata.fda.gov
Colorimetry, AcetaminophenLDP2Repackager or relabeleraccessdata.fda.gov
Coronavirus Antigen Detection Test System.QKPNRepackager or relabeleraccessdata.fda.gov
Cryptosporidium Spp.MHJ2Repackager or relabeleraccessdata.fda.gov
Dengue Nucleic Acid Amplification Assay (Naat)OZB2Repackager or relabeleraccessdata.fda.gov
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensPMT2Repackager or relabeleraccessdata.fda.gov
Device, General Purpose, Microbiology, DiagnosticLIB1Repackager or relabeleraccessdata.fda.gov
Device, Oxidase Test For GonorrheaLGA3Repackager or relabeleraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Repackager or relabeleraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Repackager or relabeleraccessdata.fda.gov
Direct Agglutination Test, Toxoplasma GondiiLLA2Repackager or relabeleraccessdata.fda.gov
Dna Probe, Trichomonas VaginalisMJK1Repackager or relabeleraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Fetal FibronectinLKV3Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMURepackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)LJC1Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RotavirusLIQ1Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorption Assay, Treponema PallidumLIP2Repackager or relabeleraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Repackager or relabeleraccessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlDAP2Repackager or relabeleraccessdata.fda.gov
Fluorometric Method, Cpk Or IsoenzymesJHX2Repackager or relabeleraccessdata.fda.gov
For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test SystemNUKNRepackager or relabeleraccessdata.fda.gov
Gabapentin AssayOTF2Repackager or relabeleraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Repackager or relabeleraccessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemPCH2Repackager or relabeleraccessdata.fda.gov
Giardia Spp.MHI2Repackager or relabeleraccessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemPGX2Repackager or relabeleraccessdata.fda.gov
Helicobacter PyloriLYR1Repackager or relabeleraccessdata.fda.gov
Hepatitis A Test (Antibody And Igm Antibody)LOL2Repackager or relabeleraccessdata.fda.gov
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion SamplesPGI2Repackager or relabeleraccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Repackager or relabeleraccessdata.fda.gov
Immunoassay, Insulin-Like Growth Factor Binding Protein-1OAM1Repackager or relabeleraccessdata.fda.gov
Immunochemical, TransferrinJNM2Repackager or relabeleraccessdata.fda.gov
Immunohistochemical Assay, Helicobacter PyloriOWF1Repackager or relabeleraccessdata.fda.gov
Immunohistochemistry Antibody Assay, C-KitNKF3Repackager or relabeleraccessdata.fda.gov
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)JIR1Repackager or relabeleraccessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid AssayOZE2Repackager or relabeleraccessdata.fda.gov
Influenza A Virus Subtype Differentiation Nucleic Acid AssayOEP2Repackager or relabeleraccessdata.fda.gov
Kit, Test, Alpha-Fetoprotein For Neural Tube DefectsLOK3Repackager or relabeleraccessdata.fda.gov
Kit, Test, Multiple, Drugs Of Abuse, Over The CounterMVOURepackager or relabeleraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Repackager or relabeleraccessdata.fda.gov
Lactoferrin, Antigen, Antiserum, ControlDEG1Repackager or relabeleraccessdata.fda.gov
Lateral Flow Immunochromatography Assay For Host Infection BiomarkersQGN2Repackager or relabeleraccessdata.fda.gov
Leishmania Spp. Antigen Detection AssayPIT1Repackager or relabeleraccessdata.fda.gov
Liquid Chromatography, AmphetamineDNI2Repackager or relabeleraccessdata.fda.gov
MNAMNARepackager or relabeleraccessdata.fda.gov
Meprobamate Test SystemQBK2Repackager or relabeleraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Repackager or relabeleraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Repackager or relabeleraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Repackager or relabeleraccessdata.fda.gov
Norovirus Serological ReagentOUC2Repackager or relabeleraccessdata.fda.gov
Nucleic Amplification Assays For The Detection Of Leishmania Nucleic AcidsOUZ1Repackager or relabeleraccessdata.fda.gov
Orientia Spp. (Scrub Typhus) Serological ReagentsQIQNRepackager or relabeleraccessdata.fda.gov
Plasmodium Spp. Detection ReagentsOAX2Repackager or relabeleraccessdata.fda.gov
Prescription Use Blood Glucose Meter For Near-Patient TestingPZI2Repackager or relabeleraccessdata.fda.gov
Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate CancersOWM2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Immunoglobulins (G, A, M)CFQ2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Lsd (125-I)DLB2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, MethaqualoneKXS2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Repackager or relabeleraccessdata.fda.gov
Reagent, Borrelia Serological ReagentLSR2Repackager or relabeleraccessdata.fda.gov
Reagent, Occult BloodKHE2Repackager or relabeleraccessdata.fda.gov
Reagents, Antibody, Legionella, Direct & Indirect FluorescentLHL2Repackager or relabeleraccessdata.fda.gov
Reagents, Clostridium Difficile ToxinLLH1Repackager or relabeleraccessdata.fda.gov
Reagents, Test, TetrahydrocannabinolDKE2Repackager or relabeleraccessdata.fda.gov
Reagents, Zika Virus Nucleic AcidPOANRepackager or relabeleraccessdata.fda.gov
Refractometer For Clinical UseJRE1Repackager or relabeleraccessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay SystemOCC2Repackager or relabeleraccessdata.fda.gov
Rubella, Other AssaysLSD2Repackager or relabeleraccessdata.fda.gov
Semen Analysis DevicePOV2Repackager or relabeleraccessdata.fda.gov
Seminal Fluid, Antigen, Antiserum, ControlDGB1Repackager or relabeleraccessdata.fda.gov
System, Identification, Hepatitis B AntigenKSJ3Repackager or relabeleraccessdata.fda.gov
System, Test, Blood Glucose, Over The CounterNBW2Repackager or relabeleraccessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerNIG2Repackager or relabeleraccessdata.fda.gov
System, Test, Carcinoembryonic AntigenDHX2Repackager or relabeleraccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Repackager or relabeleraccessdata.fda.gov
System, Test, Vitamin DMRG2Repackager or relabeleraccessdata.fda.gov
Test System, Nicotine, Cotinine, MetabolitesMRS1Repackager or relabeleraccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Repackager or relabeleraccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Repackager or relabeleraccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Repackager or relabeleraccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Repackager or relabeleraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Repackager or relabeleraccessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)LTK2Repackager or relabeleraccessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The CounterNGA1Repackager or relabeleraccessdata.fda.gov
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2Repackager or relabeleraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Repackager or relabeleraccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Repackager or relabeleraccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Repackager or relabeleraccessdata.fda.gov
Test, Morphine, Over The CounterNGI2Repackager or relabeleraccessdata.fda.gov
Test, Natriuretic PeptideNBC2Repackager or relabeleraccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Repackager or relabeleraccessdata.fda.gov
Test, Phencyclidine (Pcp), Over The CounterNGMURepackager or relabeleraccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Repackager or relabeleraccessdata.fda.gov
Test, Qualitative, Detection Of Dengue Igm And Igg AntibodiesNWYNRepackager or relabeleraccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Repackager or relabeleraccessdata.fda.gov
Test, Urine LeukocyteLJX1Repackager or relabeleraccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Repackager or relabeleraccessdata.fda.gov
Thin Layer Chromatography, MorphineDNK2Repackager or relabeleraccessdata.fda.gov
Thin Layer Chromatography, PropoxypheneDPN2Repackager or relabeleraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 30, 2025K252607AllTest Urinary Tract Infection TestJMTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
July 15, 2025K251053Shinetell PlusTM Digital Early Pregnancy TestLCXSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
April 4, 2025K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
February 27, 2025K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
September 27, 2024K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
June 17, 2024K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFTSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
April 5, 2024K234152ACESO Early Pregnancy TestLCXSubstantially EquivalentAceso Laboratories, Inc.accessdata.fda.gov
December 13, 2023K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxDKZSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
October 26, 2023K233417AllTest Fentanyl Urine Test CassetteNGLSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
July 31, 2023K231698AllTest Fentanyl Rapid Test (Urine)DJGSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
January 31, 2022K203272Alltest Pregnancy Rapid Combo Test CassetteJHISubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
March 27, 2019K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)DKZSubstantially EquivalentHangzhou AllTest Biotech Co., Ltd.accessdata.fda.gov
May 18, 2018K180771Acro HCG Pregnancy Rapid TestLCXSubstantially EquivalentAcro Biotech, Inc.accessdata.fda.gov
February 2, 2018K172512ACRO HCG Pregnancy Rapid TestLCXSubstantially EquivalentAcro Biotech, Inc.accessdata.fda.gov
October 4, 2011K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTDICSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
August 7, 2006K060355ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000DJCSubstantially EquivalentAcro Biotech, LLCaccessdata.fda.gov
July 28, 2006K060354ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000JXMSubstantially EquivalentAcro Biotech, LLCaccessdata.fda.gov
July 14, 2006K061065FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25KHESubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
June 15, 2006K053037ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100DJGSubstantially EquivalentAcro Biotech, LLCaccessdata.fda.gov
June 6, 2006K053034ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000LDJSubstantially EquivalentAcro Biotech, LLCaccessdata.fda.gov
June 6, 2006K053033ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000DJCSubstantially EquivalentAcro Biotech, LLCaccessdata.fda.gov
May 5, 2006K053035ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000DIOSubstantially EquivalentAcro Biotech, LLCaccessdata.fda.gov
May 3, 2006K060353ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000LCMSubstantially EquivalentAcro Biotech, LLCaccessdata.fda.gov
February 9, 2006K053032ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000DKZSubstantially EquivalentAcro Biotech, LLCaccessdata.fda.gov
August 16, 2005K051526URITEK-720+ URINE ANALYZERKQOSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
February 11, 1997K964461ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TESTJHISubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
May 1, 1996K960733MINISTICK PREGNANCY TESTLCXSubstantially EquivalentVanguard Biomedical Corp.accessdata.fda.gov
March 25, 1993K930014PROCLINIC ONE-STEP DIPSTICK PREGNANCY TESTJHISubstantially EquivalentVanguard Biomedical Corp.accessdata.fda.gov
October 17, 1991K914254HOMECLINIC ONE STEP PREGNANCY TESTLCXSubstantially EquivalentVanguard Biomedical Corp.accessdata.fda.gov
October 11, 1991K914253PROCLINIC ONE STEP PREGNANCY TESTJHISubstantially EquivalentVanguard Biomedical Corp.accessdata.fda.gov
March 21, 1991K910351MINICLINIC OVULATION PREDICTION TESTCEPSubstantially EquivalentVanguard Biomedical Corp.accessdata.fda.gov

Compare with other makers

Updated October 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.