The following data is part of a premarket notification filed by Cytotech, Inc. with the FDA for Cytotech Cmv Igg Eia.
| Device ID | K860493 |
| 510k Number | K860493 |
| Device Name: | CYTOTECH CMV IGG EIA |
| Classification | Antiserum, Cf, Cytomegalovirus |
| Applicant | CYTOTECH, INC. 11035 ROSELLE STREET, SUITE A San Diego, CA 92121 |
| Contact | Tamerius, Ph.d. |
| Correspondent | Tamerius, Ph.d. CYTOTECH, INC. 11035 ROSELLE STREET, SUITE A San Diego, CA 92121 |
| Product Code | GQI |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-10 |
| Decision Date | 1986-05-20 |