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

Name: FDA 510(k) clearance K944698
Creator: U.S. Food and Drug Administration
Published: 1995-03-21

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.. Device class: 1.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code CFT
Device class: Class 1
Regulation: 21 CFR 862.1625
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 ↗

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