Panels › Microbiology › Product code JWX · Class 1
Kit, Screening, Staphylococcus Aureus
Regulation 866.2660
0510(k)s in 12 months (20 all time)
0recalls in 12 months (7 all time)
2recalls that name a 510(k)
Top companies in JWX
| Company | 510(k)s | Recalls |
|---|---|---|
| Remel, L.P. | 1 | 3 |
| Biomerieux Inc | 0 | 2 |
| NERL Diagnostics Corporation | 0 | 2 |
| Advanced Medical Technology, Inc. | 1 | 0 |
| American Micro Scan | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Binax, Inc. | 1 | 0 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Connecticut Diagnostics, Ltd. | 1 | 0 |
| Difco Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 2009 | K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST Binax, Inc. | JWX |
| Sep 8, 1997 | K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS Oxoid , Ltd., GB | JWX |
| Feb 7, 1997 | K964315 | REMEL STAPH LATEX KIT Remel, L.P. | JWX |
| Jun 1, 1995 | K945538 | STAPHAUREX PLUS(TM) Murex Diagnostics Limitd, DE | JWX |
| Aug 10, 1993 | K926173 | STAPH-A-LEX(TM) SYSTEM Trinity Laboratories, Inc. | JWX |
| Sep 28, 1992 | K923212 | SLIDEX STAPH-KIT Biomerieux Vitek, Inc. | JWX |
| Mar 29, 1991 | K905617 | VISI-STAPH Connecticut Diagnostics, Ltd. | JWX |
| Jun 18, 1990 | K902259 | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT Orthomet, Inc. | JWX |
| Oct 28, 1987 | K874019 | STAPHSLIDE Ncs Diagnostics, Inc., CA | JWX |
| Mar 4, 1986 | K854278 | NEG COMBO BREAKPOINT PANEL POS COMBO American Micro Scan | JWX |
| Mar 3, 1986 | K855220 | V-TREND KIT STAPH LATEX TEST Texas Immunology, Inc. | JWX |
| Aug 19, 1985 | K852997 | RAPI - STAPH Advanced Medical Technology, Inc. | JWX |
| Oct 1, 1984 | K843560 | BACTO STAPHYLOCOCCUS LATEX TEST Difco Laboratories, Inc. | JWX |
| Jun 8, 1983 | K831918 | LA-STAPH IDENTIFICATION SYSTEM Immuno-Mycologics, Inc. | JWX |
| Apr 8, 1983 | K830783 | VERI-STAPH Zeus Technologies | JWX |
| Sep 14, 1982 | K822558 | LSM AGAR Granite Diagnostics, Inc. | JWX |
| Aug 24, 1982 | K822144 | IDS STAPHYLOCHROME TEST Innovative Diagnostic Systems, Inc. | JWX |
| Jul 30, 1982 | K821962 | BBL STAPHYSLIDE TEST Bd Becton Dickinson Vacutainer Systems Preanalytic | JWX |
| Feb 4, 1982 | K813614 | STAPH TRAC Dms Laboratories | JWX |
| May 5, 1981 | K811098 | SERO-STAT STAPHYLOCOCCUS TEST Scott Laboratories, Inc. | JWX |
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