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FDA 510(k)

HEMOLAB

K-Number: K931992 · 1994-12-22

ApplicantBiomerieux Vitek, Inc.
Decision Date1994-12-22
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOLAB 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 1994-12-22 under 510(k) number K931992. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOLAB?

HEMOLAB is a medical device that received FDA 510(k) clearance on 1994-12-22. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K931992.

When did HEMOLAB receive FDA 510(k) clearance?

HEMOLAB received FDA 510(k) clearance on 1994-12-22, under 510(k) number K931992.

Who is the listed applicant for HEMOLAB?

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 HEMOLAB?

The FDA product code for HEMOLAB is GKP.

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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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