IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT— 510(k) K882674

Name: FDA 510(k) clearance K882674
Creator: U.S. Food and Drug Administration
Published: 1989-08-15

Substantially Equivalent

Icn Immunobiologicals

FDA 510(k) clearance K882674 for IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT, Substantially Equivalent on 1989-08-15. Applicant: Icn Immunobiologicals. Device class: 1.

Clearance details

Applicant: Icn Immunobiologicals
Product code: Code LKH
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1988-06-28
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, US

Download summary PDF View on FDA.gov ↗

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