VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
FDA 510(k) clearance K984567 · decided 1999-08-12
Clearance details
- K-number
- K984567
- Device name
- VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
- Applicant
- Ventana, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-23
- Decision date
- 1999-08-12
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- MYA
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection k recall (Z-2716-2011) | Ventana Medical Systems Inc | 2011-07-01 |
| iView DAB Detection Kit, Part number: 760-091 (05266157001) This detection kit is intended recall (Z-2717-2011) | Ventana Medical Systems Inc | 2011-07-01 |