The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Epstein-barr Viral Capsid Antigen Igm #5590.
Device ID | K883871 |
510k Number | K883871 |
Device Name: | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 |
Classification | Epstein-barr Virus, Other |
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 | LSE |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-13 |
Decision Date | 1989-07-14 |