JSS · Class I · 21 CFR 866.2660

FDA Product Code JSS: Kit, Identification, Enterobacteriaceae

Leading manufacturers include Advandx, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Vitek 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 Oct 01, 2015
hemoFISH Masterpanel
K150031
Miacom Diagnostics GmbH
Microbiology · 266d
Cleared Jul 21, 2013
GRAM-NEGATIVE QUICKFISH BC
K123418
Advandx, Inc.
Microbiology · 257d
Cleared Dec 16, 2010
GNR TRAFFIC LIGHT PNA FISH
K101558
Advandx, Inc.
Microbiology · 195d
Cleared Dec 16, 2009
E.COLI/P. AERUGINOSA PNA FISH
K092236
Advandx, Inc.
Microbiology · 146d
Cleared Sep 01, 2009
EK/P. AERUGINOSA PNA FISH
K092393
Advandx, Inc.
Microbiology · 27d
Cleared Jun 25, 2009
E. COLI PNA FISH
K082068
Advandx, Inc.
Microbiology · 338d
Cleared Mar 26, 2009
EK/P. AERUGINOSA PNA FISH
K081433
Advandx, Inc.
Microbiology · 309d
Cleared Dec 19, 2008
E.COLI/P. AERUGINOSA PNA FISH
K081309
Advandx, Inc.
Microbiology · 224d
Cleared Sep 23, 1993
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
K926002
Alamar Biosciences Laboratory, Inc.
Microbiology · 300d
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 Feb 04, 1982
RAPID E
K813609
Dms Laboratories
Microbiology · 37d
Cleared Dec 31, 1981
SYSTEK #1 EIKEN
K813164
Syn-Kit, Inc.
Microbiology · 51d

About Product Code JSS - Regulatory Context