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FDA 510(k)

FIBRI-PREST/THROMBIN-PREST CONTROLS

K-Number: K884385 · 1988-12-28

ApplicantAmerican Bioproducts Co.
Decision Date1988-12-28
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRI-PREST/THROMBIN-PREST CONTROLS 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 1988-12-28 under 510(k) number K884385. The device is classified under product code GJA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRI-PREST/THROMBIN-PREST CONTROLS?

FIBRI-PREST/THROMBIN-PREST CONTROLS is a medical device that received FDA 510(k) clearance on 1988-12-28. The listed applicant is American Bioproducts Co.. The 510(k) number is K884385.

When did FIBRI-PREST/THROMBIN-PREST CONTROLS receive FDA 510(k) clearance?

FIBRI-PREST/THROMBIN-PREST CONTROLS received FDA 510(k) clearance on 1988-12-28, under 510(k) number K884385.

Who is the listed applicant for FIBRI-PREST/THROMBIN-PREST CONTROLS?

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 FIBRI-PREST/THROMBIN-PREST CONTROLS?

The FDA product code for FIBRI-PREST/THROMBIN-PREST CONTROLS is GJA.

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Other records listing American Bioproducts Co. as applicant

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Related Devices (Code: GJA)

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.

K050817T-TEKR2 Diagnostics, Inc.K982209ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589Sigma Diagnostics, Inc.K970645BC THROMBIN REAGENTBehring Diagnostics, Inc.K925493BIOMERIEUX HEMOLAB THROMBICALCI-TESTBiomerieux Vitek, Inc.K930157TEST THROMBINBehring Diagnostics, Inc.K923220THROMBIN CLOT TIME TEST PROCEDUREMedical Laboratory Automation Systems, Inc.

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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