The following data is part of a premarket notification filed by Amico Lab, Inc. with the FDA for Amizyme-ebv Test Kit.
| Device ID | K842530 |
| 510k Number | K842530 |
| Device Name: | AMIZYME-EBV TEST KIT |
| Classification | Antiserum, Cf, Epstein-barr Virus |
| Applicant | AMICO LAB, INC. TN 37209 - |
| Product Code | GNP |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-28 |
| Decision Date | 1985-12-06 |