The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearview C. Diff A.
| Device ID | K955067 |
| 510k Number | K955067 |
| Device Name: | CLEARVIEW C. DIFF A |
| Classification | Antigen, C. Difficile |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | Louise Roberts |
| Correspondent | Louise Roberts UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | MCB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-06 |
| Decision Date | 1996-09-13 |