JWX — Kit, Screening, Staphylococcus Aureus Class I
FDA Device Classification
Classification Details
- Product Code
- JWX
- 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 |
|---|
| K090964 | binax | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | December 16, 2009 |
| K972030 | oxoid | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS | September 8, 1997 |
| K964315 | remel, l.p | REMEL STAPH LATEX KIT | February 7, 1997 |
| K945538 | murex diagnostics limitd | STAPHAUREX PLUS(TM) | June 1, 1995 |
| K926173 | trinity laboratories | STAPH-A-LEX(TM) SYSTEM | August 10, 1993 |
| K923212 | biomerieux vitek | SLIDEX STAPH-KIT | September 28, 1992 |
| K905617 | connecticut diagnostics | VISI-STAPH | March 29, 1991 |
| K902259 | orthomet | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT | June 18, 1990 |
| K874019 | ncs diagnostics | STAPHSLIDE | October 28, 1987 |
| K854278 | american micro scan | NEG COMBO BREAKPOINT PANEL POS COMBO | March 4, 1986 |
| K855220 | texas immunology | V-TREND KIT STAPH LATEX TEST | March 3, 1986 |
| K852997 | advanced medical technology | RAPI - STAPH | August 19, 1985 |
| K843560 | difco laboratories | BACTO STAPHYLOCOCCUS LATEX TEST | October 1, 1984 |
| K831918 | immuno-mycologics | LA-STAPH IDENTIFICATION SYSTEM | June 8, 1983 |
| K830783 | zeus technologies | VERI-STAPH | April 8, 1983 |
| K822558 | granite diagnostics | LSM AGAR | September 14, 1982 |
| K822144 | innovative diagnostic systems | IDS STAPHYLOCHROME TEST | August 24, 1982 |
| K821962 | bd becton dickinson vacutainer systems preanalytic | BBL STAPHYSLIDE TEST | July 30, 1982 |
| K813614 | dms laboratories | STAPH TRAC | February 4, 1982 |
| K811098 | scott laboratories | SERO-STAT STAPHYLOCOCCUS TEST | May 5, 1981 |