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FDA 510(k)

PROTEIN C REAGENT

K-Number: K002541 · 2000-09-26

ApplicantDade Behring, Inc.
Decision Date2000-09-26
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTEIN C REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2000-09-26 under 510(k) number K002541. 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 PROTEIN C REAGENT?

PROTEIN C REAGENT is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Dade Behring, Inc.. The 510(k) number is K002541.

When did PROTEIN C REAGENT receive FDA 510(k) clearance?

PROTEIN C REAGENT received FDA 510(k) clearance on 2000-09-26, under 510(k) number K002541.

Who is the listed applicant for PROTEIN C REAGENT?

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

What is the FDA product code for PROTEIN C REAGENT?

The FDA product code for PROTEIN C REAGENT is GGP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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