AVL OMNI ANALYZER
FDA 510(k) clearance K954018 · decided 1995-10-05
Clearance details
- K-number
- K954018
- Device name
- AVL OMNI ANALYZER
- Applicant
- Avl Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-25
- Decision date
- 1995-10-05
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- GKR
- Device class
- 2
- Regulation number
- 864.5620
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 2 Analyzer; catalog numbers GD0335 and GD0335R. recall (Z-0330-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591. recall (Z-0331-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R . recall (Z-0332-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R. recall (Z-0333-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591. recall (Z-0334-04) | Roche Diagnostics Corp. | 2004-07-20 |
| 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 |