The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Alcohol Calibrators.
| Device ID | K853532 |
| 510k Number | K853532 |
| Device Name: | ALCOHOL CALIBRATORS |
| Classification | Calibrators, Ethyl Alcohol |
| 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 | DNN |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-23 |
| Decision Date | 1985-09-16 |