FDA Product Code
FDA Product Code OVQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6040
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100015 | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 | Abbott Molecular, Inc. | 2011-08-09 | Traditional | PDF ↗ |
| K962873 | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE | Vysis | 1997-01-13 | Traditional | PDF ↗ |
Product code OVQ · Class II · Immunology. Data: openFDA.