The following data is part of a premarket notification filed by Enzo Biochem, Inc. with the FDA for Colorgene Dna Hybridization Test For Hsv Confirma..
| Device ID | K870733 |
| 510k Number | K870733 |
| Device Name: | COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. |
| Classification | Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 |
| Applicant | ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Contact | Olsiewski, Phd |
| Correspondent | Olsiewski, Phd 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 | 1987-02-25 |
| Decision Date | 1987-05-26 |