The following data is part of a premarket notification filed by Vysis with the FDA for Cep 12 Spectrumorange Direct Labeled Chromosome Enumeration Dna Probe.
| Device ID | K962873 |
| 510k Number | K962873 |
| Device Name: | CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE |
| Classification | Chronic Lymphocytic Leukemia Fish Probe Kit |
| 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 | OVQ |
| CFR Regulation Number | 866.6040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-23 |
| Decision Date | 1997-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884999027084 | K962873 | 000 |
| 00884999027015 | K962873 | 000 |