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FDA 510(k)

THROMBIN CLOT TIME TEST PROCEDURE

K-Number: K923220 · 1992-09-29

ApplicantMedical Laboratory Automation Systems, Inc.
Decision Date1992-09-29
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBIN CLOT TIME TEST PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laboratory Automation Systems, Inc.. It received FDA 510(k) clearance on 1992-09-29 under 510(k) number K923220. 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 THROMBIN CLOT TIME TEST PROCEDURE?

THROMBIN CLOT TIME TEST PROCEDURE is a medical device that received FDA 510(k) clearance on 1992-09-29. The listed applicant is Medical Laboratory Automation Systems, Inc.. The 510(k) number is K923220.

When did THROMBIN CLOT TIME TEST PROCEDURE receive FDA 510(k) clearance?

THROMBIN CLOT TIME TEST PROCEDURE received FDA 510(k) clearance on 1992-09-29, under 510(k) number K923220.

Who is the listed applicant for THROMBIN CLOT TIME TEST PROCEDURE?

The FDA 510(k) record lists Medical Laboratory Automation Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THROMBIN CLOT TIME TEST PROCEDURE?

The FDA product code for THROMBIN CLOT TIME TEST PROCEDURE is GJA.

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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.K920147THROMBIN CLOTTING TIME REAGENTHelena Laboratories

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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