The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Human C4 Complement Control Serum.
| Device ID | K772004 |
| 510k Number | K772004 |
| Device Name: | HUMAN C4 COMPLEMENT CONTROL SERUM |
| Classification | Complement C4, Antigen, Antiserum, Control |
| Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBI |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-21 |
| Decision Date | 1977-11-03 |