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

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..

Clearance details

Applicant
Organon Teknika Corp.
Product code
Code JNL
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Durham, NC, US
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