JSS — Kit, Identification, Enterobacteriaceae Class I
FDA product code JSS covers "Kit, Identification, Enterobacteriaceae", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JSS
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150031 | miacom diagnostics | hemoFISH Masterpanel | October 1, 2015 |
| K123418 | advandx | GRAM-NEGATIVE QUICKFISH BC | July 21, 2013 |
| K101558 | advandx | GNR TRAFFIC LIGHT PNA FISH | December 16, 2010 |
| K092236 | advandx | E.COLI/P. AERUGINOSA PNA FISH | December 16, 2009 |
| K092393 | advandx | EK/P. AERUGINOSA PNA FISH | September 1, 2009 |
| K082068 | advandx | E. COLI PNA FISH | June 25, 2009 |
| K081433 | advandx | EK/P. AERUGINOSA PNA FISH | March 26, 2009 |
| K081309 | advandx | E.COLI/P. AERUGINOSA PNA FISH | December 19, 2008 |
| K926002 | alamar biosciences laboratory | ALAMAR BACTERIAL IDENTIFICATION TEST PANEL | September 23, 1993 |
| K926018 | becton dickinson microbiology systems | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM | March 11, 1993 |
| K926017 | becton dickinson microbiology systems | CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM | March 11, 1993 |
| K924814 | analytical products | API 20E/UNISCEPT 20E | March 11, 1993 |
| K922588 | roche diagnostic systems | ROCHE ENTEROTUBE II | September 11, 1992 |
| K912924 | rantran | RAMBACH AGAR | February 28, 1992 |
| K894776 | radiometer america | SENSITITRE INDOLE REAGENT | August 31, 1989 |
| K890626 | dms products | RAPIDEC COLI | June 2, 1989 |
| K883558 | vitek systems | VITEK GRAM-NEGATIVE IDENTIFICATION CARD | September 16, 1988 |
| K863603 | bd becton dickinson vacutainer systems preanalytic | GI MOTILITY TEST MEDIUM W/TTC | September 30, 1986 |
| K861774 | microtech medical systems | QUADRA-TITER (TM) I.D. (MODIFICATION) | May 20, 1986 |
| K854733 | dms products | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) | March 6, 1986 |