AURAFLEX TG-AB AND TPO-AB— 510(k) K951320

Name: FDA 510(k) clearance K951320
Creator: U.S. Food and Drug Administration
Published: 1995-08-25

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K951320 for AURAFLEX TG-AB AND TPO-AB, Substantially Equivalent on 1995-08-25. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code JNL
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1995-03-23
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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