Cleared Traditional

ACCUPACE GROUP A STREPTOCOCCUS ID TEST

K915852 · Gen-Probe, Inc. · Microbiology
Apr 1992
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K915852 is an FDA 510(k) clearance for the ACCUPACE GROUP A STREPTOCOCCUS ID 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 April 2, 1992, 97 days after receiving the submission on December 27, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K915852 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1991
Decision Date April 02, 1992
Days to Decision 97 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MDK — Dna-probe, Reagents, Streptococcal
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740