CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST— 510(k) K901243

Name: FDA 510(k) clearance K901243
Creator: U.S. Food and Drug Administration
Published: 1990-05-21

Substantially Equivalent

Cel Labs Pty, Ltd.

FDA 510(k) clearance K901243 for CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST, Substantially Equivalent on 1990-05-21. Applicant: Cel Labs Pty, Ltd.. Device class: 1.

Clearance details

Applicant: Cel Labs Pty, Ltd.
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1990-03-15
Decision date: 1990-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.