The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Vysis D7s486/cep 7 Fish Probe Kit.
| Device ID | K131508 |
| 510k Number | K131508 |
| Device Name: | VYSIS D7S486/CEP 7 FISH PROBE KIT |
| Classification | Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders |
| Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Contact | Nancy W Bengtson |
| Correspondent | Nancy W Bengtson ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Product Code | PFG |
| CFR Regulation Number | 864.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-24 |
| Decision Date | 2013-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884999036406 | K131508 | 000 |