The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Immunoglobulins M.
| Device ID | K873871 |
| 510k Number | K873871 |
| Device Name: | IMMUNOGLOBULINS M |
| Classification | Igm, 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 | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-24 |
| Decision Date | 1987-10-13 |