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Data / Medical devices / United States / American Laboratory Products Company

American Laboratory Products Company: FDA-registered device maker in Salem, NH, United States, 18 510(k) clearances

American Laboratory Products Company is registered with the FDA (registration 1222302) in Salem, NH, United States. It lists 38 device types. The FDA files 18 510(k) clearances under its listings, the newest dated April 13, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch American Laboratory Products Company
FDA registration number
1222302
FEI number
1000121039
Address
26 Keewaydin Drive Unit G, Salem, NH, United States, 03079
Owner or operator
AMERICAN LABORATORY PRODUCTS CO., LTD. (9000664)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed
December 4, 2007
Registered through
2026
Brand names listed
17-?-OH Progesterone ELISA, 17-alpha Hydroxy Progesterone ELISA, 17-alpha Hydroxy Progesterone ELISA (Saliva), 25OH Vitamin D Total ELISA, ACTH EIA, ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Calprotectin Turbidimetric Assay, ALPCO Easy Stool Extraction Device and more

Devices it lists

DeviceProduct codeClassRoleSource
Anti-Dna Antibody, Antigen And ControlLSW2Repackager or relabeleraccessdata.fda.gov
Antigen, Agglutinating, Echinococcus Spp.GPF1Repackager or relabeleraccessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, ControlsLJM2Repackager or relabeleraccessdata.fda.gov
Assay, ErythropoietinGGT2Repackager or relabeleraccessdata.fda.gov
Autoantibodies, Endomysial(Tissue Transglutaminase)MVM2Repackager or relabeleraccessdata.fda.gov
Calprotectin, FecalNXO2Manufactureraccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Repackager or relabeleraccessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And ControlLLL2Repackager or relabeleraccessdata.fda.gov
General Purpose ReagentPPM1Manufactureraccessdata.fda.gov
Ige, Antigen, Antiserum, ControlDGC2Repackager or relabeleraccessdata.fda.gov
Lactoferrin, Antigen, Antiserum, ControlDEG1Complaint file establishment, Manufactureraccessdata.fda.gov
P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), TrypsinJNN1Manufactureraccessdata.fda.gov
Radioimmunoassay, 17-HydroxyprogesteroneJLX1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, ActhCKG2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, AndrostenedioneCIZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, C-Peptides Of ProinsulinJKD1Manufactureraccessdata.fda.gov
Radioimmunoassay, CalcitoninJKR2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)JKC1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstradiolCHP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstriolCGI1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, EstroneCGF1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, GlucagonJME1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Human Growth HormoneCFL1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Immunoreactive InsulinCFP1Manufactureraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Parathyroid HormoneCEW2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, PregnenoloneJNG1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, ProgesteroneJLS1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Total Estrogens, NonpregnancyJMD1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Repackager or relabeleraccessdata.fda.gov
System, Test, Anticardiolipin ImmunologicalMID2Repackager or relabeleraccessdata.fda.gov
System, Test, Vitamin DMRG2Repackager or relabeleraccessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)MSV2Repackager 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
April 13, 2023K220763ALPCO Calprotectin Immunoturbidimetric AssayNXOSubstantially EquivalentALPCOaccessdata.fda.gov
October 25, 2019K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceNXOSubstantially EquivalentALPCOaccessdata.fda.gov
July 15, 2013K12336425OH VITAMIN D TOTAL ELISA TESTMRGSubstantially EquivalentDiasource Immunoassays, S.A.accessdata.fda.gov
January 29, 2008K062534ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEJLXSubstantially EquivalentDrg Intl., Inc.accessdata.fda.gov
December 13, 2006K062217AESKULSKA BETA2-GLYCO-AMSVSubstantially EquivalentAesku, Inc.accessdata.fda.gov
June 1, 2005K042644AESKULISA TTG A AND AESKULISA TTG GMVMSubstantially EquivalentAesku, Inc.accessdata.fda.gov
October 14, 2004K041628AESKULISA DS DNA GLSWSubstantially EquivalentAesku Diagnosticsaccessdata.fda.gov
May 12, 2004K040463AESKULISA CARDIOLIPIN AGMMIDSubstantially EquivalentAesku, Inc.accessdata.fda.gov
December 16, 2003K032469AESKULISA ANA 8PROLLLSubstantially EquivalentAesku, Inc.accessdata.fda.gov
August 18, 2003K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITCDZSubstantially EquivalentDiagnostics Biochem Canada, Inc.accessdata.fda.gov
February 8, 2002K014120TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)CDZSubstantially EquivalentDiagnostics Biochem Canada, Inc.accessdata.fda.gov
June 7, 2000K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITGGTSubstantially EquivalentSangui Biotech, Inc.accessdata.fda.gov
September 21, 1999K992528BIOCHECK IGE ELISA, MODEL BC-1035DGCSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
July 22, 1999K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHISubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
June 2, 1999K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLISubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
September 3, 1998K982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITJKRSubstantially EquivalentSangui Biotech, Inc.accessdata.fda.gov
August 19, 1998K982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITCKGSubstantially EquivalentSangui Biotech, Inc.accessdata.fda.gov
December 23, 1997K974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISACEWSubstantially EquivalentSangui Biotech, Inc.accessdata.fda.gov

Compare with other makers

Updated April 13, 2023. 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.