GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS— 510(k) K043072

Name: FDA 510(k) clearance K043072
Creator: U.S. Food and Drug Administration
Published: 2005-01-27

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K043072 for GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, Substantially Equivalent on 2005-01-27. Applicant: Gen-Probe, Inc.. Device class: 1.

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code MKZ
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 2004-11-08
Decision date: 2005-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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