K944698

Substantially Equivalent

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1

Applicant: Organon Teknika Corp.
Product 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

Download summary PDF View on FDA.gov ↗

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