FDA 510(k)

FIBRINOSTIKA FBDP MICROELISA SYSTEM

K-Number: K912876 · 1991-10-09

Decision Date1991-10-09

Product CodeDAP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FIBRINOSTIKA FBDP MICROELISA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1991-10-09 under 510(k) number K912876. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOSTIKA FBDP MICROELISA SYSTEM?

FIBRINOSTIKA FBDP MICROELISA SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Organon Teknika Corp.. The 510(k) number is K912876.

When did FIBRINOSTIKA FBDP MICROELISA SYSTEM receive FDA 510(k) clearance?

FIBRINOSTIKA FBDP MICROELISA SYSTEM received FDA 510(k) clearance on 1991-10-09, under 510(k) number K912876.

Who is the listed applicant for FIBRINOSTIKA FBDP MICROELISA SYSTEM?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIBRINOSTIKA FBDP MICROELISA SYSTEM?

The FDA product code for FIBRINOSTIKA FBDP MICROELISA SYSTEM is DAP.

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Other records listing Organon Teknika Corp. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.