MDK · Class I · 21 CFR 866.3740

FDA Product Code MDK: Dna-probe, Reagents, Streptococcal

Leading manufacturers include Gen-Probe, Inc. and Chugai Pharmaceuticals Co., Ltd..

4
Total
4
Cleared
246d
Avg days
1990
Since

FDA 510(k) Cleared Dna-probe, Reagents, Streptococcal Devices (Product Code MDK)

4 devices
1–4 of 4
Cleared Sep 24, 1998
GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
K974572
Chugai Pharmaceuticals Co., Ltd.
Microbiology · 293d
Cleared Mar 11, 1994
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
K924715
Gen-Probe, Inc.
Microbiology · 536d
Cleared Apr 02, 1992
ACCUPACE GROUP A STREPTOCOCCUS ID TEST
K915852
Gen-Probe, Inc.
Microbiology · 97d
Cleared Nov 13, 1990
ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.
K904268
Gen-Probe, Inc.
Microbiology · 56d

About Product Code MDK - Regulatory Context