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FDA 510(k)

FDP ASSAY-20 TEST KIT

K-Number: K852848 · 1985-10-10

ApplicantAmerican Bioproducts Co.
Decision Date1985-10-10
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FDP ASSAY-20 TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1985-10-10 under 510(k) number K852848. The device is classified under product code GHH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FDP ASSAY-20 TEST KIT?

FDP ASSAY-20 TEST KIT is a medical device that received FDA 510(k) clearance on 1985-10-10. The listed applicant is American Bioproducts Co.. The 510(k) number is K852848.

When did FDP ASSAY-20 TEST KIT receive FDA 510(k) clearance?

FDP ASSAY-20 TEST KIT received FDA 510(k) clearance on 1985-10-10, under 510(k) number K852848.

Who is the listed applicant for FDP ASSAY-20 TEST KIT?

The FDA 510(k) record lists American Bioproducts Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FDP ASSAY-20 TEST KIT?

The FDA product code for FDP ASSAY-20 TEST KIT is GHH.

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Other records listing American Bioproducts Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KIT

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Related Devices (Code: GHH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme LaboratoriesK072288PATHFAST D-DIMERMitsubishi Kagaku IatronK070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (IrishK062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite IncorporatedK030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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