The following data is part of a premarket notification filed by Enzo Biochem, Inc. with the FDA for Colorgene Fluorescent Dna Hybridization Test / Cmv.
| Device ID | K875367 |
| 510k Number | K875367 |
| Device Name: | COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV |
| Classification | Antisera, Neutralization, Herpesvirus Hominis |
| Applicant | ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Contact | Paula Olsiewski |
| Correspondent | Paula Olsiewski ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Product Code | GQM |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-31 |
| Decision Date | 1988-03-28 |