The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Easy Analyzer & Easy-test Reagent.
| Device ID | K853699 |
| 510k Number | K853699 |
| Device Name: | EASY ANALYZER & EASY-TEST REAGENT |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-04 |
| Decision Date | 1985-09-25 |