The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vidas Chlamydia Assay, Modification.
| Device ID | K915884 |
| 510k Number | K915884 |
| Device Name: | VIDAS CHLAMYDIA ASSAY, MODIFICATION |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| 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 | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-12 |
| Decision Date | 1992-03-04 |