PREDICTOR HOME PREGNANCY TEST— 510(k) K940637

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K940637 for PREDICTOR HOME PREGNANCY TEST, Substantially Equivalent on 1994-06-02. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 1994-02-14
Decision date: 1994-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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