The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Emds Antiepileptic Drug Calibrators Item #67630/95.
| Device ID | K862403 |
| 510k Number | K862403 |
| Device Name: | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 |
| Classification | Calibrators, Drug Mixture |
| Applicant | DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Raymond L Miller |
| Correspondent | Raymond L Miller DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-26 |
| Decision Date | 1986-07-11 |