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FDA 510(k)

IL TEST (TM) PT-FIBRINOGEN HS PLUS

K-Number: K933252 · 1993-10-04

ApplicantInstrumentation Laboratory CO
Decision Date1993-10-04
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IL TEST (TM) PT-FIBRINOGEN HS PLUS 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 1993-10-04 under 510(k) number K933252. 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 (TM) PT-FIBRINOGEN HS PLUS?

IL TEST (TM) PT-FIBRINOGEN HS PLUS is a medical device that received FDA 510(k) clearance on 1993-10-04. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K933252.

When did IL TEST (TM) PT-FIBRINOGEN HS PLUS receive FDA 510(k) clearance?

IL TEST (TM) PT-FIBRINOGEN HS PLUS received FDA 510(k) clearance on 1993-10-04, under 510(k) number K933252.

Who is the listed applicant for IL TEST (TM) PT-FIBRINOGEN HS PLUS?

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 (TM) PT-FIBRINOGEN HS PLUS?

The FDA product code for IL TEST (TM) PT-FIBRINOGEN HS PLUS 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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