JSS
49 FDA 510(k) clearances · Product code
50 daysmedian time to decision
257 days90th percentile
49clearances measured
FDA profile
- Official device name
- Kit, Identification, Enterobacteriaceae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| hemoFISH Masterpanel (K150031) | Miacom Diagnostics GmbH | 2015-10-01 |
| GRAM-NEGATIVE QUICKFISH BC (K123418) | Advandx, Inc. | 2013-07-21 |
| GNR TRAFFIC LIGHT PNA FISH (K101558) | Advandx, Inc. | 2010-12-16 |
| E.COLI/P. AERUGINOSA PNA FISH (K092236) | Advandx, Inc. | 2009-12-16 |
| EK/P. AERUGINOSA PNA FISH (K092393) | Advandx, Inc. | 2009-09-01 |
| E. COLI PNA FISH (K082068) | Advandx, Inc. | 2009-06-25 |
| EK/P. AERUGINOSA PNA FISH (K081433) | Advandx, Inc. | 2009-03-26 |
| E.COLI/P. AERUGINOSA PNA FISH (K081309) | Advandx, Inc. | 2008-12-19 |
| ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (K926002) | Alamar Biosciences Laboratory, Inc. | 1993-09-23 |
| API 20E/UNISCEPT 20E (K924814) | Analytical Products, Inc. | 1993-03-11 |
| CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (K926017) | Becton Dickinson Microbiology Systems | 1993-03-11 |
| CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (K926018) | Becton Dickinson Microbiology Systems | 1993-03-11 |
| ROCHE ENTEROTUBE II (K922588) | Roche Diagnostic Systems, Inc. | 1992-09-11 |
| RAMBACH AGAR (K912924) | Rantran, Inc. | 1992-02-28 |
| SENSITITRE INDOLE REAGENT (K894776) | Radiometer America, Inc. | 1989-08-31 |
| RAPIDEC COLI (K890626) | Dms Products, Inc. | 1989-06-02 |
| VITEK GRAM-NEGATIVE IDENTIFICATION CARD (K883558) | Vitek Systems, Inc. | 1988-09-16 |
| GI MOTILITY TEST MEDIUM W/TTC (K863603) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-09-30 |
| QUADRA-TITER (TM) I.D. (MODIFICATION) (K861774) | Microtech Medical Systems, Inc. | 1986-05-20 |
| API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) (K854733) | Dms Products, Inc. | 1986-03-06 |
| COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT (K853009) | Roche Diagnostic Systems, Inc. | 1986-03-04 |
| QUADRA-TITER I.D. (K860208) | Microtech Medical Systems, Inc. | 1986-03-03 |
| IDS RAPID SS/U SYSTEM (K852871) | Innovative Diagnostic Systems, Inc. | 1985-07-23 |
| IDS RAPID E PLUS SYSTEM (K852110) | Innovative Diagnostic Systems, Inc. | 1985-06-04 |
| LYFO-KWIK OMI KIT (K851978) | Micro-Bio-Logics | 1985-06-04 |
| RIM-UREA (K843571) | Austin Biological Laboratories | 1984-10-01 |
| TITERTEK ENTEROBAC* (K834090) | Flow Laboratories, Inc. | 1984-01-13 |
| FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI (K833612) | Petra Biomedical Products, Inc. | 1983-12-12 |
| FLUOR-B MEL A DIRECT FLUORESCENT ANTI (K833613) | Petra Biomedical Products, Inc. | 1983-12-12 |
| SPECTRUM-10 (K831672) | Austin Biological Laboratories | 1983-06-22 |
| QUANTUM II BACTERIAL IDENT. SYSTEM (K830698) | Abbott Laboratories | 1983-04-08 |
| UREA-PDA DISK (K830396) | Remel Co. | 1983-03-08 |
| RAPID E (K813609) | Dms Laboratories | 1982-02-04 |
| SYSTEK #1 EIKEN (K813164) | Syn-Kit, Inc. | 1981-12-31 |
| MINITECK ENTERIC BROTH & ENTEROBACTER (K812286) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-10-02 |
| SENSITITIRE AP60 (K811765) | Gibco Laboratories Life Technologies, Inc. | 1981-08-13 |
| SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS (K811434) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-06-26 |
| ENTERIC-TEK (K792058) | Flow Laboratories, Inc. | 1980-01-11 |
| 3M MICROBIAL PROFILE SYSTEM GRAM (K791789) | 3M Company | 1979-11-16 |
| AMS ENTEROBACTERIACEASE CARE (K791932) | Vitek Systems, Inc. | 1979-11-13 |
| STREP-SPEC (K791991) | Micro-Media Systems, Inc. | 1979-11-13 |
| CORD, ENTEROBACTERIACEAE BIOCHEMICAL (K782056) | Vitek Systems, Inc. | 1979-01-26 |
| INOCULATOR, AIM-4 MICROPROCESSOR (K781816) | Axford Manufacturing , Ltd. | 1978-12-07 |
| MICRODILUTION GRAM-NEGATIVE ID. PANEL (K781368) | Cnr Labs | 1978-10-03 |
| MICRODILUTION STREP ID. PANEL (K781367) | Cnr Labs | 1978-10-03 |
| MS-2 BACTERIAL ID. SYSTEM (K781427) | Abbott Laboratories | 1978-09-27 |
| ENTEROTUBE II (K781236) | Hoffmann-La Roche, Inc. | 1978-08-31 |
| ENTERIC 20 (K771703) | Inolex Corp./Div of Biomedical | 1977-10-04 |
| MICRO-ID (K760790) | General Diagnostics | 1976-10-29 |
Track JSS automatically
Every clearance here is in the API, with alerts when new ones post.