JWX
20 FDA 510(k) clearances · Product code
37 daysmedian time to decision
245 days90th percentile
20clearances measured
FDA profile
- Official device name
- Kit, Screening, Staphylococcus Aureus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BINAXNOX STAPHYLOCOCCUS AUREUS TEST (K090964) | Binax, Inc. | 2009-12-16 |
| STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (K972030) | Oxoid , Ltd. | 1997-09-08 |
| REMEL STAPH LATEX KIT (K964315) | Remel, L.P. | 1997-02-07 |
| STAPHAUREX PLUS(TM) (K945538) | Murex Diagnostics Limitd | 1995-06-01 |
| STAPH-A-LEX(TM) SYSTEM (K926173) | Trinity Laboratories, Inc. | 1993-08-10 |
| SLIDEX STAPH-KIT (K923212) | Biomerieux Vitek, Inc. | 1992-09-28 |
| VISI-STAPH (K905617) | Connecticut Diagnostics, Ltd. | 1991-03-29 |
| AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT (K902259) | Orthomet, Inc. | 1990-06-18 |
| STAPHSLIDE (K874019) | Ncs Diagnostics, Inc. | 1987-10-28 |
| NEG COMBO BREAKPOINT PANEL POS COMBO (K854278) | American Micro Scan | 1986-03-04 |
| V-TREND KIT STAPH LATEX TEST (K855220) | Texas Immunology, Inc. | 1986-03-03 |
| RAPI - STAPH (K852997) | Advanced Medical Technology, Inc. | 1985-08-19 |
| BACTO STAPHYLOCOCCUS LATEX TEST (K843560) | Difco Laboratories, Inc. | 1984-10-01 |
| LA-STAPH IDENTIFICATION SYSTEM (K831918) | Immuno-Mycologics, Inc. | 1983-06-08 |
| VERI-STAPH (K830783) | Zeus Technologies | 1983-04-08 |
| LSM AGAR (K822558) | Granite Diagnostics, Inc. | 1982-09-14 |
| IDS STAPHYLOCHROME TEST (K822144) | Innovative Diagnostic Systems, Inc. | 1982-08-24 |
| BBL STAPHYSLIDE TEST (K821962) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-07-30 |
| STAPH TRAC (K813614) | Dms Laboratories | 1982-02-04 |
| SERO-STAT STAPHYLOCOCCUS TEST (K811098) | Scott Laboratories, Inc. | 1981-05-05 |
Track JWX automatically
Every clearance here is in the API, with alerts when new ones post.