CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
FDA 510(k) clearance K962873 · decided 1997-01-13
Clearance details
- K-number
- K962873
- Device name
- CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
- Applicant
- Vysis
- Decision
- Substantially Equivalent
- Date received
- 1996-07-23
- Decision date
- 1997-01-13
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- OVQ
- Device class
- 2
- Regulation number
- 866.6040
- 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 |
|---|---|---|
| VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 (K100015) | Abbott Molecular, Inc. | 2011-08-09 |
Recalls involving this device
No recalls on record reference this clearance.