The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Cytomegalovirus (cmv) Elisa Test Sys. Cat. No:4530.
| Device ID | K854666 |
| 510k Number | K854666 |
| Device Name: | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 |
| Classification | Antiserum, Cf, Cytomegalovirus |
| Applicant | CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
| Contact | Marylou Panico |
| Correspondent | Marylou Panico CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
| Product Code | GQI |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-21 |
| Decision Date | 1986-02-05 |