The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Hsvi - Igg Elisa-kit.
Device ID | K852782 |
510k Number | K852782 |
Device Name: | HSVI - 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 |