ETI-MAX 3000

Analyzer, Chemistry, Micro, For Clinical Use

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Eti-max 3000.

Pre-market Notification Details

Device IDK052794
510k NumberK052794
Device Name:ETI-MAX 3000
ClassificationAnalyzer, Chemistry, Micro, For Clinical Use
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
ContactCarol A Depouw
CorrespondentCarol A Depouw
DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater,  MN  55082
Product CodeJJF  
CFR Regulation Number862.2170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-03
Decision Date2006-03-31
Summary:summary

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