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FDA 510(k)

BIOMERIEUX HEMOLAB COFAC II

K-Number: K942049 · 1995-05-19

ApplicantBiomerieux Vitek, Inc.
Decision Date1995-05-19
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOMERIEUX HEMOLAB COFAC II 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 1995-05-19 under 510(k) number K942049. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMERIEUX HEMOLAB COFAC II?

BIOMERIEUX HEMOLAB COFAC II is a medical device that received FDA 510(k) clearance on 1995-05-19. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K942049.

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

BIOMERIEUX HEMOLAB COFAC II received FDA 510(k) clearance on 1995-05-19, under 510(k) number K942049.

Who is the listed applicant for BIOMERIEUX HEMOLAB COFAC II?

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 COFAC II?

The FDA product code for BIOMERIEUX HEMOLAB COFAC II is GJT.

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Official Source

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