The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Cytomegalovirus Igg Eia Test Kit.
| Device ID | K843189 |
| 510k Number | K843189 |
| Device Name: | CYTOMEGALOVIRUS IGG EIA TEST KIT |
| Classification | Antiserum, Cf, Cytomegalovirus |
| Applicant | LABSYSTEMS, INC. IL 60648 - |
| Product Code | GQI |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-13 |
| Decision Date | 1986-01-08 |