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 |