The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Eti-max 3000.
| Device ID | K052794 |
| 510k Number | K052794 |
| Device Name: | ETI-MAX 3000 |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Carol A Depouw |
| Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2006-03-31 |
| Summary: | summary |