The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Eni Antibody To Epstein-barr Virus.
Device ID | K810860 |
510k Number | K810860 |
Device Name: | ENI ANTIBODY TO EPSTEIN-BARR VIRUS |
Classification | Antiserum, Cf, Epstein-barr Virus |
Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GNP |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-03-30 |
Decision Date | 1981-05-05 |