The following data is part of a premarket notification filed by Amico Laboratories, Inc. with the FDA for Amizyme Epstein-barr Virus (ebv) Igm Antibody Test.
| Device ID | K911362 |
| 510k Number | K911362 |
| Device Name: | AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| Applicant | AMICO LABORATORIES, INC. P.O. BOX 90203 Nashville, TN 37209 |
| Contact | A. M Isa |
| Correspondent | A. M Isa AMICO LABORATORIES, INC. P.O. BOX 90203 Nashville, TN 37209 |
| Product Code | LJN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-10-07 |