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FDA 510(k)

COAMATIC FACTOR VIII

K-Number: K981038 · 1998-04-16

ApplicantInstrumentation Laboratory CO
Decision Date1998-04-16
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAMATIC FACTOR VIII 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 1998-04-16 under 510(k) number K981038. 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 COAMATIC FACTOR VIII?

COAMATIC FACTOR VIII is a medical device that received FDA 510(k) clearance on 1998-04-16. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K981038.

When did COAMATIC FACTOR VIII receive FDA 510(k) clearance?

COAMATIC FACTOR VIII received FDA 510(k) clearance on 1998-04-16, under 510(k) number K981038.

Who is the listed applicant for COAMATIC FACTOR VIII?

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 COAMATIC FACTOR VIII?

The FDA product code for COAMATIC FACTOR VIII 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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