JSY · Class I · 21 CFR 866.2660

FDA Product Code JSY: Kit, Identification, Mycobacteria

Leading manufacturers include Dynagen, Inc., Analytical Products, Inc. and Alpha-Tec Systems, Inc..

5
Total
5
Cleared
170d
Avg days
1983
Since

FDA 510(k) Cleared Kit, Identification, Mycobacteria Devices (Product Code JSY)

5 devices
1–5 of 5
Cleared Mar 13, 1995
MYCOAKT M. AVIUM CULTURE ID KIT
K943049
Dynagen, Inc.
Microbiology · 259d
Cleared Mar 13, 1995
MYCOAKT M KANSASII CULTURE ID KIT
K943050
Dynagen, Inc.
Microbiology · 259d
Cleared Mar 13, 1995
MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT
K943051
Dynagen, Inc.
Microbiology · 259d
Cleared Mar 24, 1988
ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION
K880990
Alpha-Tec Systems, Inc.
Pathology · 16d
Cleared Mar 24, 1983
API TB-IDENT*
K830211
Analytical Products, Inc.
Microbiology · 59d

About Product Code JSY - Regulatory Context