AURAFLEX TPO-AB— 510(k) K952607

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K952607 for AURAFLEX 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: 1995-05-31
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.