The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Human Serum Anticonvulsant Drug Control.
| Device ID | K843818 |
| 510k Number | K843818 |
| Device Name: | HUMAN SERUM ANTICONVULSANT DRUG CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | QUANTIMETRIX CORP. 11953 SOURTH PRAIRIE AVE Hawthorne , CA 90250 - |
| Contact | Arthur F Wells |
| Correspondent | Arthur F Wells QUANTIMETRIX CORP. 11953 SOURTH PRAIRIE AVE Hawthorne , CA 90250 - |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-28 |
| Decision Date | 1984-10-30 |