The following data is part of a premarket notification filed by Amico Lab, Inc. with the FDA for Anti-cytomegalovirus Kit.
| Device ID | K842661 |
| 510k Number | K842661 |
| Device Name: | ANTI-CYTOMEGALOVIRUS KIT |
| Classification | Antiserum, Cf, Cytomegalovirus |
| Applicant | AMICO LAB, INC. TN 37209 - |
| Product Code | GQI |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1985-12-06 |