The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vidas Chlamydia Assay Vitek Immundiag Assay Syst.
| Device ID | K905787 |
| 510k Number | K905787 |
| Device Name: | VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | VITEK SYSTEMS, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Winters Heard |
| Correspondent | Winters Heard VITEK SYSTEMS, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-04-29 |