The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearview Strep A.
| Device ID | K893422 |
| 510k Number | K893422 |
| Device Name: | CLEARVIEW STREP A |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | Mr. G Zajicek |
| Correspondent | Mr. G Zajicek UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-02 |
| Decision Date | 1989-06-23 |