Cleared Traditional

ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.

K904268 · Gen-Probe, Inc. · Microbiology

Nov 1990

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K904268 is an FDA 510(k) clearance for the ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM., 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 November 13, 1990, 56 days after receiving the submission on September 18, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K904268 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 1990
Decision Date	November 13, 1990
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—