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FDA 510(k)

HEMOSIL RECOMBI PLASTIN

K-Number: K012768 · 2001-09-18

ApplicantInstrumentation Laboratory CO
Decision Date2001-09-18
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSIL RECOMBI PLASTIN 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 2001-09-18 under 510(k) number K012768. 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 HEMOSIL RECOMBI PLASTIN?

HEMOSIL RECOMBI PLASTIN is a medical device that received FDA 510(k) clearance on 2001-09-18. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K012768.

When did HEMOSIL RECOMBI PLASTIN receive FDA 510(k) clearance?

HEMOSIL RECOMBI PLASTIN received FDA 510(k) clearance on 2001-09-18, under 510(k) number K012768.

Who is the listed applicant for HEMOSIL RECOMBI PLASTIN?

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 HEMOSIL RECOMBI PLASTIN?

The FDA product code for HEMOSIL RECOMBI PLASTIN is 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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