ROCHE OXI/FERM II
FDA 510(k) clearance K923313 · decided 1993-04-05
Clearance details
- K-number
- K923313
- Device name
- ROCHE OXI/FERM II
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-07
- Decision date
- 1993-04-05
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- LQM
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Branchburg, NJ, 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 |
|---|---|---|
| VITEK RAPID CALL-GRAM NEGATIV IDENT CARD (K925915) | Biomerieux Vitek, Inc. | 1993-03-23 |
| 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.