FDA 510(k)

FIBRINOSTIKA TDP MICROELISA SYSTEM

K-Number: K915698 · 1992-08-05

Decision Date1992-08-05

Product CodeDAP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

FIBRINOSTIKA TDP 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 1992-08-05 under 510(k) number K915698. 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 TDP MICROELISA SYSTEM?

FIBRINOSTIKA TDP MICROELISA SYSTEM is a medical device that received FDA 510(k) clearance on 1992-08-05. The listed applicant is Organon Teknika Corp.. The 510(k) number is K915698.

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

FIBRINOSTIKA TDP MICROELISA SYSTEM received FDA 510(k) clearance on 1992-08-05, under 510(k) number K915698.

Who is the listed applicant for FIBRINOSTIKA TDP 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 TDP MICROELISA SYSTEM?

The FDA product code for FIBRINOSTIKA TDP 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.