FIRST RESPONSE(R) ONE-STEP— 510(k) K914304

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K914304 for FIRST RESPONSE(R) ONE-STEP, Substantially Equivalent on 1991-10-17. Applicant: Armkel, LLC.

Clearance details

Applicant: Armkel, LLC
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 1991-09-25
Decision date: 1991-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

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