JSS · Class I · 21 CFR 866.2660

FDA Product Code JSS: Kit, Identification, Enterobacteriaceae

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Abbott Laboratories and Roche Diagnostic Systems, Inc..

49
Total
49
Cleared
91d
Avg days
1976
Since

FDA 510(k) Cleared Kit, Identification, Enterobacteriaceae Devices (Product Code JSS)

49 devices
1–24 of 49
Cleared Sep 11, 1992
ROCHE ENTEROTUBE II
K922588
Roche Diagnostic Systems, Inc.
Microbiology · 102d
Cleared Sep 30, 1986
GI MOTILITY TEST MEDIUM W/TTC
K863603
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 15d
Cleared Mar 04, 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009
Roche Diagnostic Systems, Inc.
Microbiology · 231d
Cleared Apr 08, 1983
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698
Abbott Laboratories
Microbiology · 32d
Cleared Oct 02, 1981
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 50d
Cleared Jun 26, 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 35d
Cleared Nov 16, 1979
3M MICROBIAL PROFILE SYSTEM GRAM
K791789
3M Company
Microbiology · 63d
Cleared Sep 27, 1978
MS-2 BACTERIAL ID. SYSTEM
K781427
Abbott Laboratories
Microbiology · 36d

About Product Code JSS - Regulatory Context