The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Ics Normal Control Serum.
| Device ID | K781355 |
| 510k Number | K781355 |
| Device Name: | ICS NORMAL CONTROL SERUM |
| Classification | Whole Human Serum, Antigen, Antiserum, Control |
| Applicant | BECKMAN INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGR |
| CFR Regulation Number | 866.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-07 |
| Decision Date | 1978-08-31 |