RAPID NFT, MODIFICATION
FDA 510(k) clearance K922768 · decided 1992-10-14
Clearance details
- K-number
- K922768
- Device name
- RAPID NFT, MODIFICATION
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-08
- Decision date
- 1992-10-14
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- JSW
- 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 |
|---|---|---|
| RAPID NF SYSTEM (K900517) | Innovative Diagnostic Systems, Inc. | 1990-03-13 |
| AUSTIN NONFERMENTER KIT (K870769) | Austin Biological Laboratories | 1987-04-03 |
| PSEUDO-PALETTE TM (K790992) | Micro-Palettes, Inc. | 1979-06-22 |
| NON-FERMENTER SYSTEM (K772112) | Corning Medical & Scientific | 1977-11-17 |
| PANEL, GNF, MICRO-ID (K770745) | Micro-Media Systems, Inc. | 1977-06-23 |
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 |