The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Epstein-barr Virus (ebna-1) Igm Cata. #5550.
| Device ID | K883601 |
| 510k Number | K883601 |
| Device Name: | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 |
| Classification | Test, Antigen, Nuclear, Epstein-barr Virus |
| 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 | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-23 |
| Decision Date | 1989-05-11 |