SLIDEX STAPH-KIT
FDA 510(k) clearance K923212 · decided 1992-09-28
Clearance details
- K-number
- K923212
- Device name
- SLIDEX STAPH-KIT
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-01
- Decision date
- 1992-09-28
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JWX
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hazelwood, MO, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agg recall (Z-1045-2012) | bioMerieux, Inc. | 2012-02-16 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146) | Biomerieux Vitek, Inc. | 2001-10-17 |
| VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145) | Biomerieux Vitek, Inc. | 2001-06-25 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142) | Biomerieux Vitek, Inc. | 2001-05-30 |
| VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141) | Biomerieux Vitek, Inc. | 2001-05-14 |
| VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140) | Biomerieux Vitek, Inc. | 2001-03-09 |
| VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138) | Biomerieux Vitek, Inc. | 2000-08-11 |