FDA Product Code
FDA Product Code PDO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1870
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN130010 | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) | Abbott Molecular, Inc. | 2013-07-29 | Post-NSE | — |
Product code PDO · Class II · Hematology. Data: openFDA.