The following data is part of a premarket notification filed by Vysis with the FDA for Cep 8 Spectrumorange Dna Probe Kit.
| Device ID | K953591 |
| 510k Number | K953591 |
| Device Name: | CEP 8 SPECTRUMORANGE DNA PROBE KIT |
| Classification | Dna-probe Kit, Human Chromosome |
| Applicant | VYSIS 3100 WOODCREEK DR. Downers Grove, IL 60515 |
| Contact | Russell K Enns |
| Correspondent | Russell 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 | 1995-08-01 |
| Decision Date | 1996-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884999027077 | K953591 | 000 |
| 00884999027046 | K953591 | 000 |
| 00884999027039 | K953591 | 000 |
| 00884999027008 | K953591 | 000 |