JTW — System, Transport, Aerobic Class I
FDA product code JTW covers "System, Transport, Aerobic", a Class I medical device regulated under 21 CFR 866.2900. 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
- JTW
- Device Class
- Class I
- Regulation Number
- 866.2900
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K121039 | copan flock technologies | COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | May 25, 2012 |
| K061301 | copan diagnostics | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM | June 23, 2006 |
| K022874 | gen-probe | GEN-PROBE APTIMA COMBO 2 ASSAY | September 17, 2002 |
| K013819 | sierra diagnostic | URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM | February 28, 2002 |
| K993161 | copan diagnostics | COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM | November 9, 1999 |
| K983244 | trek diagnostic systems | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) | November 30, 1998 |
| K961148 | difco laboratories | CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) | April 26, 1996 |
| K934894 | difco laboratories | CULTURESWAB TRANSPORT SYSTEM | February 22, 1994 |
| K904773 | gibson laboratories | P AND T MEDIUM | December 4, 1990 |
| K895187 | fairleigh dickinson laboratories | FDL, INC.'S TRANSPORT SYSTEM | October 24, 1989 |
| K882580 | precision dynamics | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | July 8, 1988 |
| K872325 | technology management and marketing | GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT | August 12, 1987 |
| K872326 | technology management and marketing | GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT | August 11, 1987 |
| K843359 | applied polytechnology | URINE TRANSPORT KIT | September 27, 1984 |
| K843341 | bd becton dickinson vacutainer systems preanalytic | GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK | September 27, 1984 |
| K843173 | difco laboratories | CELL-MATICS VIRAL TRANSPORT PACK | September 6, 1984 |
| K840719 | great lakes intl | BAKTERIETTE-VI-PAK | April 4, 1984 |
| K840991 | preventive diagnostics | PRESERV BUFFERED GLYCEROL SALINE | March 23, 1984 |
| K840968 | preventive diagnostics | PRESERV TRANSPORT & CULTURE PACK | March 23, 1984 |
| K840990 | preventive diagnostics | PRESERV CARY BLAIR TRANSPORT PACK | March 23, 1984 |