The following data is part of a premarket notification filed by Gilford with the FDA for Gilford Tri-level Assayed Immunology Control.
| Device ID | K851202 |
| 510k Number | K851202 |
| Device Name: | GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | GILFORD 17392 DAIMLER ST. Irvine, CA 92714 |
| Contact | Ronald D Schaefer |
| Correspondent | Ronald D Schaefer GILFORD 17392 DAIMLER ST. Irvine, CA 92714 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-26 |
| Decision Date | 1985-04-29 |