NATIVE PROTHROMBIN ANTIGEN EIA— 510(k) K910617

Name: FDA 510(k) clearance K910617
Creator: U.S. Food and Drug Administration
Published: 1991-05-15

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K910617 for NATIVE PROTHROMBIN ANTIGEN EIA, Substantially Equivalent on 1991-05-15. Applicant: Organon Teknika Corp.. Device class: 1.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code DDF
Device class: Class 1
Regulation: 21 CFR 866.5735
Advisory panel: Immunology
Date received: 1991-02-12
Decision date: 1991-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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