The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearview Positive And Negative Urine Hcg Contol Set.
| Device ID | K934923 |
| 510k Number | K934923 |
| Device Name: | CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-13 |
| Decision Date | 1993-12-29 |