GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199— 510(k) K063451

Name: FDA 510(k) clearance K063451
Creator: U.S. Food and Drug Administration
Published: 2007-01-22

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K063451 for GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199, Substantially Equivalent on 2007-01-22. 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: 2006-11-15
Decision date: 2007-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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