Cleared Traditional

GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820

K974572 · Chugai Pharmaceuticals Co., Ltd. · Microbiology
Sep 1998
Decision
293d
Days
Class 1
Risk

About This 510(k) Submission

K974572 is an FDA 510(k) clearance for the GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820, a Dna-probe, Reagents, Streptococcal (Class I — General Controls, product code MDK), submitted by Chugai Pharmaceuticals Co., Ltd. (San Diedgo, US). The FDA issued a Cleared decision on September 24, 1998, 293 days after receiving the submission on December 5, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K974572 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 1997
Decision Date September 24, 1998
Days to Decision 293 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