CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY— 510(k) K895122

Name: FDA 510(k) clearance K895122
Creator: U.S. Food and Drug Administration
Published: 1989-10-30

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K895122 for CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY, Substantially Equivalent on 1989-10-30. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1989-08-15
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

Download summary PDF View on FDA.gov ↗

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