The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Albumin In Serum.
| Device ID | K873862 |
| 510k Number | K873862 |
| Device Name: | ALBUMIN IN SERUM |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | George Zajicek |
| Correspondent | George Zajicek UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-24 |
| Decision Date | 1987-10-20 |