JSS · Class I · 21 CFR 866.2660

FDA Product Code JSS: Kit, Identification, Enterobacteriaceae

Leading manufacturers include Vitek Systems, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Flow Laboratories, 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 Mar 11, 1993
API 20E/UNISCEPT 20E
K924814
Analytical Products, Inc.
Microbiology · 167d
Cleared Mar 11, 1993
CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM
K926017
Becton Dickinson Microbiology Systems
Microbiology · 101d
Cleared Mar 11, 1993
CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM
K926018
Becton Dickinson Microbiology Systems
Microbiology · 101d
Cleared Sep 11, 1992
ROCHE ENTEROTUBE II
K922588
Roche Diagnostic Systems, Inc.
Microbiology · 102d
Cleared Aug 31, 1989
SENSITITRE INDOLE REAGENT
K894776
Radiometer America, Inc.
Microbiology · 35d
Cleared Sep 16, 1988
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558
Vitek Systems, Inc.
Microbiology · 28d
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 Oct 01, 1984
RIM-UREA
K843571
Austin Biological Laboratories
Microbiology · 20d
Cleared Jan 13, 1984
TITERTEK ENTEROBAC*
K834090
Flow Laboratories, Inc.
Microbiology · 46d
Cleared Jun 22, 1983
SPECTRUM-10
K831672
Austin Biological Laboratories
Microbiology · 30d
Cleared Apr 08, 1983
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698
Abbott Laboratories
Microbiology · 32d
Cleared Mar 08, 1983
UREA-PDA DISK
K830396
Remel Co.
Microbiology · 29d
Cleared Dec 31, 1981
SYSTEK #1 EIKEN
K813164
Syn-Kit, Inc.
Microbiology · 51d
Cleared Oct 02, 1981
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 50d
Cleared Aug 13, 1981
SENSITITIRE AP60
K811765
Gibco Laboratories Life Technologies, Inc.
Microbiology · 52d
Cleared Jun 26, 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 35d
Cleared Jan 11, 1980
ENTERIC-TEK
K792058
Flow Laboratories, Inc.
Microbiology · 88d
Cleared Nov 16, 1979
3M MICROBIAL PROFILE SYSTEM GRAM
K791789
3M Company
Microbiology · 63d
Cleared Nov 13, 1979
AMS ENTEROBACTERIACEASE CARE
K791932
Vitek Systems, Inc.
Microbiology · 47d
Cleared Jan 26, 1979
CORD, ENTEROBACTERIACEAE BIOCHEMICAL
K782056
Vitek Systems, Inc.
Microbiology · 46d
Cleared Sep 27, 1978
MS-2 BACTERIAL ID. SYSTEM
K781427
Abbott Laboratories
Microbiology · 36d
Cleared Aug 31, 1978
ENTEROTUBE II
K781236
Hoffmann-La Roche, Inc.
Microbiology · 42d
Cleared Oct 29, 1976
MICRO-ID
K760790
General Diagnostics
Microbiology · 22d

About Product Code JSS - Regulatory Context