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FDA 510(k)

COATEST SP FVIII

K-Number: K042576 · 2004-12-02

ApplicantInstrumentation Laboratory CO
Decision Date2004-12-02
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COATEST SP FVIII is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2004-12-02 under 510(k) number K042576. 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 COATEST SP FVIII?

COATEST SP FVIII is a medical device that received FDA 510(k) clearance on 2004-12-02. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K042576.

When did COATEST SP FVIII receive FDA 510(k) clearance?

COATEST SP FVIII received FDA 510(k) clearance on 2004-12-02, under 510(k) number K042576.

Who is the listed applicant for COATEST SP FVIII?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COATEST SP FVIII?

The FDA product code for COATEST SP FVIII is GGP.

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Related Devices (Code: 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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