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FDA 510(k)

DADE PROTEIN C CLOTTING ASSAY

K-Number: K903468 · 1991-02-26

ApplicantBaxter Healthcare Corp
Decision Date1991-02-26
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE PROTEIN C CLOTTING ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-02-26 under 510(k) number K903468. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE PROTEIN C CLOTTING ASSAY?

DADE PROTEIN C CLOTTING ASSAY is a medical device that received FDA 510(k) clearance on 1991-02-26. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K903468.

When did DADE PROTEIN C CLOTTING ASSAY receive FDA 510(k) clearance?

DADE PROTEIN C CLOTTING ASSAY received FDA 510(k) clearance on 1991-02-26, under 510(k) number K903468.

Who is the listed applicant for DADE PROTEIN C CLOTTING ASSAY?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DADE PROTEIN C CLOTTING ASSAY?

The FDA product code for DADE PROTEIN C CLOTTING ASSAY is GGP.

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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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