The following data is part of a premarket notification filed by Bio Diagnostic Intl. with the FDA for Liqui-sera Anticonvulsants Controls.
| Device ID | K831278 |
| 510k Number | K831278 |
| Device Name: | LIQUI-SERA ANTICONVULSANTS CONTROLS |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO DIAGNOSTIC INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-19 |
| Decision Date | 1983-05-27 |