VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
FDA 510(k) clearance K952095 · decided 1996-03-12
Clearance details
- K-number
- K952095
- Device name
- VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-04
- Decision date
- 1996-03-12
- Days to decision
- 313 days
- Clearance type
- Traditional
- Product code
- LQL
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (K972576) | Accumed Intl., Inc. | 1998-01-22 |
| RAPID GRAM-POSITIVE ID SYSTEM (K961730) | Becton Dickinson Microbiology Systems | 1997-02-04 |
| BBLCRYSTAL GRAM-POSITIVE ID SYSTEM (K961968) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-02-04 |
| VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD (K925916) | Biomerieux Vitek, Inc. | 1993-03-23 |
| RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (K910304) | Vitek Systems, Inc. | 1991-07-26 |
| VISI-STREP (K910537) | Kev Connecticut Diagnostics, Inc. | 1991-04-12 |
| MODIFICATION TO API UNISCEPT 20GP (K901559) | Analytical Products, Inc. | 1990-09-10 |
| RAPIDEC STAPH (K891004) | Dms Products, Inc. | 1989-11-09 |
| CATHRA GRAM POSITIVE SCREEN (K874606) | Mct Medical, Inc. | 1988-05-06 |
| GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (K863038) | American Micro Scan | 1986-09-30 |
Recalls involving this device
No recalls on record reference this clearance.
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 |