The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearview Chlamydia.
| Device ID | K895280 |
| 510k Number | K895280 |
| Device Name: | CLEARVIEW CHLAMYDIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | G. T Zajicek |
| Correspondent | G. T Zajicek UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-24 |
| Decision Date | 1990-01-29 |