CHLAMYDIA IGG ELISA TEST SYSTEM— 510(k) K962558

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K962558 for CHLAMYDIA IGG ELISA TEST SYSTEM, Substantially Equivalent on 1997-02-24. Applicant: Armkel, LLC. Device class: 1.

Clearance details

Applicant: Armkel, LLC
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1996-07-01
Decision date: 1997-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Frederick, MD, US

Download summary PDF View on FDA.gov ↗

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