VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
FDA 510(k) clearance K925915 · decided 1993-03-23
Clearance details
- K-number
- K925915
- Device name
- VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-23
- Decision date
- 1993-03-23
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- LQM
- 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 |
|---|---|---|
| ROCHE OXI/FERM II (K923313) | Roche Diagnostic Systems, Inc. | 1993-04-05 |
| SCEPTOR IDENTIFICATION SYSTEM (K912897) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-28 |
| VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (K911429) | Vitek Systems, Inc. | 1991-06-24 |
| SENSITITRE AUTO ID PLATE AP80 (K890057) | Radiometer America, Inc. | 1989-06-09 |
| GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (K862642) | American Micro Scan | 1986-09-11 |
| PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM (K851528) | Pasco Laboratories, Inc. | 1985-07-15 |
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 |