Cleared Traditional

GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST

K924715 · Gen-Probe, Inc. · Microbiology

Mar 1994

Decision

536d

Days

Class 1

Risk

About This 510(k) Submission

K924715 is an FDA 510(k) clearance for the GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST, a Dna-probe, Reagents, Streptococcal (Class I — General Controls, product code MDK), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on March 11, 1994, 536 days after receiving the submission on September 21, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K924715 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 1992
Decision Date	March 11, 1994
Days to Decision	536 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF