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FDA 510(k)

FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM

K-Number: K924892 · 1994-04-21

ApplicantOrganon Teknika Corp.
Decision Date1994-04-21
Product CodeDAT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOSTIKA(R) FGDP 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 1994-04-21 under 510(k) number K924892. The device is classified under product code DAT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM?

FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM is a medical device that received FDA 510(k) clearance on 1994-04-21. The listed applicant is Organon Teknika Corp.. The 510(k) number is K924892.

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

FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM received FDA 510(k) clearance on 1994-04-21, under 510(k) number K924892.

Who is the listed applicant for FIBRINOSTIKA(R) FGDP 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(R) FGDP MICROELISA SYSTEM?

The FDA product code for FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM is DAT.

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Related Devices (Code: DAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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