The following data is part of a premarket notification filed by Bio-reagents & Diagnostics, Inc. with the FDA for Anticonvulsant Control Serum.
| Device ID | K760730 |
| 510k Number | K760730 |
| Device Name: | ANTICONVULSANT CONTROL SERUM |
| Classification | Drug Specific Control Materials |
| Applicant | BIO-REAGENTS & DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-27 |
| Decision Date | 1976-10-07 |