The following data is part of a premarket notification filed by Adi Diagnostics, Inc. with the FDA for Visuwell(r) Chlamydia.
| Device ID | K900973 |
| 510k Number | K900973 |
| Device Name: | VISUWELL(R) CHLAMYDIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | ADI DIAGNOSTICS, INC. 30 MERIDIAN ROAD Rexdale, Ontario, CA M9w 4z7 |
| Contact | Janet Shaw |
| Correspondent | Janet Shaw ADI DIAGNOSTICS, INC. 30 MERIDIAN ROAD Rexdale, Ontario, CA M9w 4z7 |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-02 |
| Decision Date | 1990-05-15 |