AVL OMNI ANALYZER
FDA 510(k) clearance K972733 · decided 1997-09-09
Clearance details
- K-number
- K972733
- Device name
- AVL OMNI ANALYZER
- Applicant
- Avl Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-21
- Decision date
- 1997-09-09
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R. recall (Z-0335-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R. recall (Z-0336-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591. recall (Z-0337-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. recall (Z-0326-04) | Roche Diagnostics Corp. | 2004-01-10 |
| Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. recall (Z-0327-04) | Roche Diagnostics Corp. | 2004-01-10 |
| Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD0475 recall (Z-0328-04) | Roche Diagnostics Corp. | 2004-01-10 |