The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearview Hcg Serum/urine.
| Device ID | K905741 |
| 510k Number | K905741 |
| Device Name: | CLEARVIEW HCG SERUM/URINE |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | Mark Gittins |
| Correspondent | Mark Gittins UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1991-05-15 |