ANEUVYSION MULITICOLOR DNA PROBE KIT
FDA 510(k) clearance K010288 · decided 2001-04-13
Clearance details
- K-number
- K010288
- Device name
- ANEUVYSION MULITICOLOR DNA PROBE KIT
- Applicant
- Vysis
- Decision
- Substantially Equivalent
- Date received
- 2001-01-31
- Decision date
- 2001-04-13
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- OYU
- Device class
- 2
- Regulation number
- 866.4700
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Downers Grove, IL, 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 |
|---|---|---|
| ANEUVYSION (K972200) | Vysis | 1997-10-20 |
| CEP 8 SPECTRUMORANGE DNA PROBE KIT (K953591) | Vysis | 1996-11-29 |
Recalls involving this device
No recalls on record reference this clearance.