The following data is part of a premarket notification filed by Enzo Biochem, Inc. with the FDA for Colorgene Dna Hybridization Test Cmv Confirmation.
| Device ID | K872576 |
| 510k Number | K872576 |
| Device Name: | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION |
| Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
| Applicant | ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Contact | Paula J Olsiewski |
| Correspondent | Paula J Olsiewski ENZO BIOCHEM, INC. 325 HUDSON ST. New York, NY 10013 |
| Product Code | GQH |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-30 |
| Decision Date | 1987-12-04 |