The following data is part of a premarket notification filed by Vysis with the FDA for Aneuvysion Muliticolor Dna Probe Kit.
| Device ID | K010288 |
| 510k Number | K010288 |
| Device Name: | ANEUVYSION MULITICOLOR DNA PROBE KIT |
| Classification | Dna-probe Kit, Human Chromosome |
| Applicant | VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515 |
| Product Code | OYU |
| CFR Regulation Number | 866.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-31 |
| Decision Date | 2001-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884999011731 | K010288 | 000 |
| 00884999011717 | K010288 | 000 |
| 00884999011700 | K010288 | 000 |
| 00884999011694 | K010288 | 000 |
| 00884999011663 | K010288 | 000 |