CHLAMYDIAZYME DIAGNOSTIC KIT— 510(k) K900543

Name: FDA 510(k) clearance K900543
Creator: U.S. Food and Drug Administration
Published: 1990-05-03

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K900543 for CHLAMYDIAZYME DIAGNOSTIC KIT, Substantially Equivalent on 1990-05-03. 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: 1990-02-05
Decision date: 1990-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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