Cleared Traditional

K061509 - TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
(FDA 510(k) Clearance)

K061509 · Gen-Probe, Inc. · Microbiology

Oct 2006

Decision

125d

Days

Class 2

Risk

K061509 is an FDA 510(k) clearance for the TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on October 4, 2006, 125 days after receiving the submission on June 1, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number	K061509 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2006
Decision Date	October 04, 2006
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement