CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC— 510(k) K831962

Name: FDA 510(k) clearance K831962
Creator: U.S. Food and Drug Administration
Published: 1983-10-05

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K831962 for CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC, Substantially Equivalent on 1983-10-05. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1983-06-17
Decision date: 1983-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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