AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1— 510(k) K944698

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K944698 for AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1, Substantially Equivalent on 1995-03-21. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code CFT
Advisory panel: Clinical Chemistry
Date received: 1994-09-23
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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