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FDA 510(k)

BIOMERIEUX HEMOLAB THROMBOMAT

K-Number: K925492 · 1993-02-03

ApplicantBiomerieux Vitek, Inc.
Decision Date1993-02-03
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOMERIEUX HEMOLAB THROMBOMAT is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1993-02-03 under 510(k) number K925492. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMERIEUX HEMOLAB THROMBOMAT?

BIOMERIEUX HEMOLAB THROMBOMAT is a medical device that received FDA 510(k) clearance on 1993-02-03. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K925492.

When did BIOMERIEUX HEMOLAB THROMBOMAT receive FDA 510(k) clearance?

BIOMERIEUX HEMOLAB THROMBOMAT received FDA 510(k) clearance on 1993-02-03, under 510(k) number K925492.

Who is the listed applicant for BIOMERIEUX HEMOLAB THROMBOMAT?

The FDA 510(k) record lists Biomerieux Vitek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMERIEUX HEMOLAB THROMBOMAT?

The FDA product code for BIOMERIEUX HEMOLAB THROMBOMAT is GJS.

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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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