The following data is part of a premarket notification filed by Icl Scientific with the FDA for Immunology Control Serum.
| Device ID | K810056 |
| 510k Number | K810056 |
| Device Name: | IMMUNOLOGY CONTROL SERUM |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-02-09 |