HEMOLAB SILIMAT REAGENT
FDA 510(k) clearance K920001 · decided 1992-09-25
Clearance details
- K-number
- K920001
- Device name
- HEMOLAB SILIMAT REAGENT
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-02
- Decision date
- 1992-09-25
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- GFI
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 (K933181) | Valleylab, Inc. | 1993-11-02 |
| ISI FENESTRATED DISSECTING AND GRASPING FORCEPS (K932534) | Innovative Surgical, Inc. | 1993-08-19 |
| OSTEOTOMES, VARIOUS TYPES (K891887) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS (K852541) | Storz Instrument Co. | 1985-07-11 |
| CHERMEL OSTEOTOMES (K842823) | Cher Mel Corp. | 1984-08-02 |
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 |