The following data is part of a premarket notification filed by Enzo Biochem, Inc. with the FDA for Colorgene Hsv Dna Hybridization Test.
| Device ID | K880604 |
| 510k Number | K880604 |
| Device Name: | COLORGENE HSV DNA HYBRIDIZATION TEST |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Contact | J Olsiewski |
| Correspondent | J Olsiewski ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Product Code | GQN |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-12 |
| Decision Date | 1988-08-03 |