The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Hsv2 - Igg Elisa-kit.
| Device ID | K852781 |
| 510k Number | K852781 |
| Device Name: | HSV2 - IGG ELISA-KIT |
| Classification | Antisera, Cf, Herpesvirus Hominis 1,2 |
| 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 | GQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-01 |
| Decision Date | 1986-01-21 |