The following data is part of a premarket notification filed by Sybron Endo/analytic with the FDA for Elements Diagnostic Unit.
| Device ID | K021298 |
| 510k Number | K021298 |
| Device Name: | ELEMENTS DIAGNOSTIC UNIT |
| Classification | Tester, Pulp |
| Applicant | SYBRON ENDO/ANALYTIC 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON ENDO/ANALYTIC 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | EAT |
| CFR Regulation Number | 872.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-24 |
| Decision Date | 2002-06-19 |
| Summary: | summary |