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FDA 510(k)

IL TEST PT-FIBRINOGEN RECOMBINANT

K-Number: K981479 · 1998-07-07

ApplicantInstrumentation Laboratory CO
Decision Date1998-07-07
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IL TEST PT-FIBRINOGEN RECOMBINANT 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 1998-07-07 under 510(k) number K981479. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL TEST PT-FIBRINOGEN RECOMBINANT?

IL TEST PT-FIBRINOGEN RECOMBINANT is a medical device that received FDA 510(k) clearance on 1998-07-07. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K981479.

When did IL TEST PT-FIBRINOGEN RECOMBINANT receive FDA 510(k) clearance?

IL TEST PT-FIBRINOGEN RECOMBINANT received FDA 510(k) clearance on 1998-07-07, under 510(k) number K981479.

Who is the listed applicant for IL TEST PT-FIBRINOGEN RECOMBINANT?

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 IL TEST PT-FIBRINOGEN RECOMBINANT?

The FDA product code for IL TEST PT-FIBRINOGEN RECOMBINANT is GJS.

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Other records listing Instrumentation Laboratory CO as applicant

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Related Devices (Code: GJS)

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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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