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FDA 510(k)

NATIVE PROTHROMBIN ANTIGEN EIA

K-Number: K910617 · 1991-05-15

ApplicantOrganon Teknika Corp.
Decision Date1991-05-15
Product CodeDDF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NATIVE PROTHROMBIN ANTIGEN EIA 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 1991-05-15 under 510(k) number K910617. The device is classified under product code DDF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATIVE PROTHROMBIN ANTIGEN EIA?

NATIVE PROTHROMBIN ANTIGEN EIA is a medical device that received FDA 510(k) clearance on 1991-05-15. The listed applicant is Organon Teknika Corp.. The 510(k) number is K910617.

When did NATIVE PROTHROMBIN ANTIGEN EIA receive FDA 510(k) clearance?

NATIVE PROTHROMBIN ANTIGEN EIA received FDA 510(k) clearance on 1991-05-15, under 510(k) number K910617.

Who is the listed applicant for NATIVE PROTHROMBIN ANTIGEN EIA?

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 NATIVE PROTHROMBIN ANTIGEN EIA?

The FDA product code for NATIVE PROTHROMBIN ANTIGEN EIA is DDF.

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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.

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