The following data is part of a De Novo classification by Abbott Molecular, Inc. with the FDA for Vysis Egr1 Fish Probe Kit - Sc (specimen Characterization).
| DeNovo ID | DEN130010 |
| Device Name: | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) |
| Classification | Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization |
| Applicant | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue Des Plaines, IL 60018 |
| Contact | Nancy W Bengtson |
| Product Code | PDO |
| CFR Regulation Number | 864.1870 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K123951 |
| Review Advisory Board | Pathology |
| Classification Advisory | Hematology |
| Type | Post-NSE |
| Date Received | 2013-04-09 |
| Decision Date | 2013-07-29 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884999038165 | DEN130010 | 000 |