KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)— 510(k) K895505

Name: FDA 510(k) clearance K895505
Creator: U.S. Food and Drug Administration
Published: 1990-01-02

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K895505 for KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES), Substantially Equivalent on 1990-01-02. Applicant: Eastman Kodak Company. Device class: 1.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1989-09-11
Decision date: 1990-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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