The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vidas Cmv Igg Assay.
| Device ID | K920661 |
| 510k Number | K920661 |
| Device Name: | VIDAS CMV IGG ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Contact | Cheryl Winters-heard |
| Correspondent | Cheryl Winters-heard VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood, MI 63042 -2395 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-13 |
| Decision Date | 1993-02-12 |