APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM— 510(k) K061413

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K061413 for APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM, Substantially Equivalent on 2006-10-13. Applicant: Gen-Probe, Inc..

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code MKZ
Advisory panel: Microbiology
Date received: 2006-05-22
Decision date: 2006-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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