Panels › Microbiology › Product code JSS · Class 1
Kit, Identification, Enterobacteriaceae
Regulation 866.2660
0510(k)s in 12 months (49 all time)
0recalls in 12 months (9 all time)
5recalls that name a 510(k)
Top companies in JSS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2015 | K150031 | hemoFISH Masterpanel Miacom Diagnostics GmbH, DE | JSS |
| Jul 21, 2013 | K123418 | GRAM-NEGATIVE QUICKFISH BC Advandx, Inc. | JSS |
| Dec 16, 2010 | K101558 | GNR TRAFFIC LIGHT PNA FISH Advandx, Inc. | JSS |
| Dec 16, 2009 | K092236 | E.COLI/P. AERUGINOSA PNA FISH Advandx, Inc. | JSS |
| Sep 1, 2009 | K092393 | EK/P. AERUGINOSA PNA FISH Advandx, Inc. | JSS |
| Jun 25, 2009 | K082068 | E. COLI PNA FISH Advandx, Inc. | JSS |
| Mar 26, 2009 | K081433 | EK/P. AERUGINOSA PNA FISH Advandx, Inc. | JSS |
| Dec 19, 2008 | K081309 | E.COLI/P. AERUGINOSA PNA FISH Advandx, Inc. | JSS |
| Sep 23, 1993 | K926002 | ALAMAR BACTERIAL IDENTIFICATION TEST PANEL Alamar Biosciences Laboratory, Inc. | JSS |
| Mar 11, 1993 | K926018 | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM Becton Dickinson Microbiology Systems | JSS |
| Mar 11, 1993 | K926017 | CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM Becton Dickinson Microbiology Systems | JSS |
| Mar 11, 1993 | K924814 | API 20E/UNISCEPT 20E Analytical Products, Inc. | JSS |
| Sep 11, 1992 | K922588 | ROCHE ENTEROTUBE II Roche Diagnostic Systems, Inc. | JSS |
| Feb 28, 1992 | K912924 | RAMBACH AGAR Rantran, Inc. | JSS |
| Aug 31, 1989 | K894776 | SENSITITRE INDOLE REAGENT Radiometer America, Inc. | JSS |
| Jun 2, 1989 | K890626 | RAPIDEC COLI Dms Products, Inc. | JSS |
| Sep 16, 1988 | K883558 | VITEK GRAM-NEGATIVE IDENTIFICATION CARD Vitek Systems, Inc. | JSS |
| Sep 30, 1986 | K863603 | GI MOTILITY TEST MEDIUM W/TTC Bd Becton Dickinson Vacutainer Systems Preanalytic | JSS |
| May 20, 1986 | K861774 | QUADRA-TITER (TM) I.D. (MODIFICATION) Microtech Medical Systems, Inc. | JSS |
| Mar 6, 1986 | K854733 | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) Dms Products, Inc. | JSS |
| Mar 4, 1986 | K853009 | COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT Roche Diagnostic Systems, Inc. | JSS |
| Mar 3, 1986 | K860208 | QUADRA-TITER I.D. Microtech Medical Systems, Inc. | JSS |
| Jul 23, 1985 | K852871 | IDS RAPID SS/U SYSTEM Innovative Diagnostic Systems, Inc. | JSS |
| Jun 4, 1985 | K852110 | IDS RAPID E PLUS SYSTEM Innovative Diagnostic Systems, Inc. | JSS |
| Jun 4, 1985 | K851978 | LYFO-KWIK OMI KIT Micro-Bio-Logics | JSS |
| Oct 1, 1984 | K843571 | RIM-UREA Austin Biological Laboratories | JSS |
| Jan 13, 1984 | K834090 | TITERTEK ENTEROBAC* Flow Laboratories, Inc. | JSS |
| Dec 12, 1983 | K833613 | FLUOR-B MEL A DIRECT FLUORESCENT ANTI Petra Biomedical Products, Inc. | JSS |
| Dec 12, 1983 | K833612 | FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI Petra Biomedical Products, Inc. | JSS |
| Jun 22, 1983 | K831672 | SPECTRUM-10 Austin Biological Laboratories | JSS |
| Apr 8, 1983 | K830698 | QUANTUM II BACTERIAL IDENT. SYSTEM Abbott Laboratories | JSS |
| Mar 8, 1983 | K830396 | UREA-PDA DISK Remel Co. | JSS |
| Feb 4, 1982 | K813609 | RAPID E Dms Laboratories | JSS |
| Dec 31, 1981 | K813164 | SYSTEK #1 EIKEN Syn-Kit, Inc. | JSS |
| Oct 2, 1981 | K812286 | MINITECK ENTERIC BROTH & ENTEROBACTER Bd Becton Dickinson Vacutainer Systems Preanalytic | JSS |
| Aug 13, 1981 | K811765 | SENSITITIRE AP60 Gibco Laboratories Life Technologies, Inc. | JSS |
| Jun 26, 1981 | K811434 | SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS Bd Becton Dickinson Vacutainer Systems Preanalytic | JSS |
| Jan 11, 1980 | K792058 | ENTERIC-TEK Flow Laboratories, Inc. | JSS |
| Nov 16, 1979 | K791789 | 3M MICROBIAL PROFILE SYSTEM GRAM 3M Company | JSS |
| Nov 13, 1979 | K791991 | STREP-SPEC Micro-Media Systems, Inc. | JSS |
| Nov 13, 1979 | K791932 | AMS ENTEROBACTERIACEASE CARE Vitek Systems, Inc. | JSS |
| Jan 26, 1979 | K782056 | CORD, ENTEROBACTERIACEAE BIOCHEMICAL Vitek Systems, Inc. | JSS |
| Dec 7, 1978 | K781816 | INOCULATOR, AIM-4 MICROPROCESSOR Axford Manufacturing , Ltd. | JSS |
| Oct 3, 1978 | K781368 | MICRODILUTION GRAM-NEGATIVE ID. PANEL Cnr Labs | JSS |
| Oct 3, 1978 | K781367 | MICRODILUTION STREP ID. PANEL Cnr Labs | JSS |
| Sep 27, 1978 | K781427 | MS-2 BACTERIAL ID. SYSTEM Abbott Laboratories | JSS |
| Aug 31, 1978 | K781236 | ENTEROTUBE II Hoffmann-La Roche, Inc. | JSS |
| Oct 4, 1977 | K771703 | ENTERIC 20 Inolex Corp./Div of Biomedical | JSS |
| Oct 29, 1976 | K760790 | MICRO-ID General Diagnostics | JSS |
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