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Data / Medical devices / United States / Sanzay Corporation -

Sanzay Corporation -: FDA-registered device maker in Miami Gardens, FL, United States, 50 510(k) clearances

Sanzay Corporation - is registered with the FDA (registration 3005146313) in Miami Gardens, FL, United States. It lists 66 device types. The FDA files 50 510(k) clearances under its listings, the newest dated June 1, 2017. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Sanzay Corporation -
FDA registration number
3005146313
Address
1080 NW 163rd Drive, Miami Gardens, FL, United States, 33169
Owner or operator
Sanzay Corporation - Integrated Diagnostics Group (10026301)
Roles
Remanufacturer, Repackager or relabeler
First device listed
July 1, 2008
Registered through
2026
Brand names listed
ACID PHOSPHATASE, ALBUMIN, ALT(SGPT), AMYLASE, AST/SGOT, Antistreptolysin O (ASO), C-REACTIVE PROTEIN (CRP) HS, C-REACTIVE PROTEIN CALIBRATOR and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid Phosphatase, Naphthyl PhosphateCKB2Repackager or relabeleraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Repackager or relabeleraccessdata.fda.gov
Activated Partial ThromboplastinGFO2Repackager or relabeleraccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Repackager or relabeleraccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Repackager or relabeleraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Antistreptolysin - Titer/Streptolysin O ReagentGTQ1Repackager or relabeleraccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Repackager or relabeleraccessdata.fda.gov
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)JJB1Repackager or relabeleraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Repackager or relabeleraccessdata.fda.gov
Blood, Occult, Colorimetric, In UrineJIO2Repackager or relabeleraccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Repackager or relabeleraccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Repackager or relabeleraccessdata.fda.gov
Calibrator For Cell IndicesKRX2Repackager or relabeleraccessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit MeasurementKRZ2Repackager or relabeleraccessdata.fda.gov
Calibrator For Platelet CountingKRY2Repackager or relabeleraccessdata.fda.gov
Calibrator For Red-Cell And White-Cell CountingKSA2Repackager or relabeleraccessdata.fda.gov
Calibrator, PrimaryJIS2Repackager or relabeleraccessdata.fda.gov
Calibrator, SecondaryJIT2Repackager or relabeleraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Repackager or relabeleraccessdata.fda.gov
Chromatographic Derivative, Total LipidsCFB1Repackager or relabeleraccessdata.fda.gov
Colorimetric Method, TriglyceridesJGY1Repackager or relabeleraccessdata.fda.gov
Colorimetry, CholinesteraseDIH1Repackager or relabeleraccessdata.fda.gov
Counter, Differential CellGKZ2Repackager or relabeleraccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Repackager or relabeleraccessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)JMT1Repackager or relabeleraccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Repackager or relabeleraccessdata.fda.gov
Diazo, Alt/SgptCJJ1Repackager or relabeleraccessdata.fda.gov
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)CDM1Repackager or relabeleraccessdata.fda.gov
Dye-Indicator, Ph (Urinary, Non-Quantitative)CEN1Repackager or relabeleraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Remanufactureraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Remanufactureraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Remanufactureraccessdata.fda.gov
Electrolyte Controls (Assayed And Unassayed)JJR1Repackager or relabeleraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Repackager or relabeleraccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Repackager or relabeleraccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Repackager or relabeleraccessdata.fda.gov
Glucose Oxidase, GlucoseCGA2Repackager or relabeleraccessdata.fda.gov
Hexokinase, GlucoseCFR2Remanufacturer, Repackager or relabeleraccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Repackager or relabeleraccessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlLBS1Repackager or relabeleraccessdata.fda.gov
Ldl & Vldl Precipitation, HdlLBR1Repackager or relabeleraccessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesCDT1Repackager or relabeleraccessdata.fda.gov
Mercuric Thiocyanate, Colorimetry, ChlorideCHJ2Repackager or relabeleraccessdata.fda.gov
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)JIL2Repackager or relabeleraccessdata.fda.gov
Mixture, Hematology Quality ControlJPK2Repackager or relabeleraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Repackager or relabeleraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesCGS2Repackager or relabeleraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Repackager or relabeleraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Repackager or relabeleraccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Repackager or relabeleraccessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)JIN1Repackager or relabeleraccessdata.fda.gov
Olive Oil Emulsion (Turbidimetric), LipaseCET1Repackager or relabeleraccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Repackager or relabeleraccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Repackager or relabeleraccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Repackager or relabeleraccessdata.fda.gov
Plasma, Coagulation ControlGGN2Repackager or relabeleraccessdata.fda.gov
Refractometer For Clinical UseJRE1Repackager or relabeleraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Repackager or relabeleraccessdata.fda.gov
System, Test, Infectious MononucleosisKTN2Repackager or relabeleraccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Repackager or relabeleraccessdata.fda.gov
Test, Time, ProthrombinGJS2Repackager or relabeleraccessdata.fda.gov
Test, Urine LeukocyteLJX1Repackager or relabeleraccessdata.fda.gov
Tetraphenyl Borate, Colorimetry, PotassiumCEJ2Repackager or relabeleraccessdata.fda.gov
Uranyl Acetate/Zinc Acetate, SodiumCEI2Repackager or relabeleraccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Repackager 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
June 1, 2017K170200Carbon Dioxide Reagent SetKHSSubstantially EquivalentTeco Diagnostics, Inc.accessdata.fda.gov
May 15, 2014K130915XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACKJJESubstantially EquivalentJas Diagnostics, Inc.accessdata.fda.gov
April 29, 2010K091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORDCFSubstantially EquivalentKamiya Biomedical Co.accessdata.fda.gov
January 22, 2008K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSLBRSubstantially EquivalentGeneral Atomicsaccessdata.fda.gov
January 3, 2008K072395DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLSLBSSubstantially EquivalentDiazyme Laboratoriesaccessdata.fda.gov
December 11, 2007K071562D3 HEMATOLOGY ANALYZER, MODEL D3GKZSubstantially EquivalentDrew Scientific, Inc.accessdata.fda.gov
August 8, 2005K051200HEMOGLOBIN A1C REAGENT SETLCPSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
May 10, 2004K040920AMYLASE LIQUID REAGENT, MODEL A532-200JFJSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
November 1, 2002K022021VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTGFOSubstantially EquivalentVital Scientific N.V.accessdata.fda.gov
July 23, 2002K022046VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROLGGNSubstantially EquivalentVital Scientific N.V.accessdata.fda.gov
May 15, 2002K020840VITAL SCIENTIFIC PT WITH CALCIUMGJSSubstantially EquivalentVital Scientific N.V.accessdata.fda.gov
March 23, 2001K003835JAS MAGNESIUM REAGENTJGJSubstantially EquivalentJas Diagnostics, Inc.accessdata.fda.gov
January 16, 2001K003991CD-CAL PLUS CALIBRATORKRXSubstantially EquivalentR&D Systems, Inc.accessdata.fda.gov
January 12, 2001K003874CBC-4K HEMATOLOGY CONTROLJPKSubstantially EquivalentR&D Systems, Inc.accessdata.fda.gov
October 13, 2000K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SETDCKSubstantially EquivalentPointe Scientific, Inc.,accessdata.fda.gov
February 8, 2000K000102GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150CFRSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
January 20, 2000K000067ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500HCJESubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
January 25, 1999K984045RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYSDHRSubstantially EquivalentKamiya Biomedical Co.accessdata.fda.gov
June 29, 1998K981650AST/SGOT LIQUID REAGENT - KINETIC METHODCITSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
April 21, 1998K981339QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3JJYSubstantially EquivalentConsolidated Technologies, Inc.accessdata.fda.gov
April 16, 1998K981106UREA NITROGEN (BUN) LIQUID REAGENTCDQSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
April 8, 1997K970250CLINISTRIPJILSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
November 25, 1996K962019C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TESTDCKSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
November 25, 1996K962015RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TESTDHRSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
October 24, 1996K961864CSF/URINE TOTAL PROTEINCEKSubstantially EquivalentTeco Diagnosticsaccessdata.fda.gov
October 16, 1992K923767PULSE IM RED CELL TESTKTNSubstantially EquivalentPulse Scientific, Inc.accessdata.fda.gov
May 13, 1992K921625CALCIUM-ARSENAZO III REAGENT SETCICSubstantially EquivalentPointe Scientific, Inc.,accessdata.fda.gov
February 21, 1992K914158URIC ACID REAGENT SETKNKSubstantially EquivalentTech Intl. Co.accessdata.fda.gov
February 18, 1992K915706LIPASE REAGENT SETCETSubstantially EquivalentTech Intl. Co.accessdata.fda.gov
January 30, 1992K914160CHOLESTEROL REGEANT SETCHHSubstantially EquivalentTech Intl. Co.accessdata.fda.gov
January 27, 1992K915709CREATINE KINASE-MB (CK-MB) REAGENT SETCGSSubstantially EquivalentTech Intl. Co.accessdata.fda.gov
January 27, 1992K914159GLUCOSE REAGENT SETCGASubstantially EquivalentTech Intl. Co.accessdata.fda.gov
December 18, 1991K914171IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASEDIHSubstantially EquivalentTech Intl. Co.accessdata.fda.gov
July 16, 1990K902495ACID PHOSPHATASE REAGENT SETCKBSubstantially EquivalentTech Intl. Co.accessdata.fda.gov
July 10, 1990K902574POTASSIUM REAGENT SETCEJSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
July 10, 1990K902572SODIUM REAGENT SETCEISubstantially EquivalentTech Intl. Co.accessdata.fda.gov
May 17, 1990K901561IRON/TOTAL IRON BINDING CAPACITYJIYSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
June 7, 1988K881172BILIRUBIN (DIRECT)CIGSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
May 27, 1988K881626GAMMA-GLUTAMYL TRANSFERASEJQBSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
April 28, 1988K881171PHOSPHORUS (INORGANIC)CEOSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
March 23, 1988K880629CREATININECGXSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
March 15, 1988K880628TRIGLYCERIDES (GPO-TRINDER)CDTSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
February 18, 1988K880176HDL CHOLESTEROL PRECIPITATING REAGENTLBRSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
January 11, 1988K875070ALBUMIN, BROMCRESOL GREEN DYE-BINDINGCIXSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
January 11, 1988K875069BILIRUBIN (TOTAL)CIGSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
December 18, 1987K874848LACTATE DEHYDROGENASE LDH-LCFJSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
December 18, 1987K874847MAGNESIUMJGJSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
January 13, 1987K864744CREATINE PHOSPHOKINASE (CK)CGSSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
January 13, 1987K864743BIURET (COLORIMETRIC), TOTAL PROTEINCEKSubstantially EquivalentTech-Co, Inc.accessdata.fda.gov
August 21, 1985K852169CHLORIDE REAGENTCHJSubstantially EquivalentPointe Scientific, Inc.,accessdata.fda.gov

Compare with other makers

Updated June 1, 2017. 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.