TECHNICON DAX(TM) SYSTEM

Analyzer, Chemistry, Centrifugal, For Clinical Use

TECHNICON INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Dax(tm) System.

Pre-market Notification Details

Device IDK885203
510k NumberK885203
Device Name:TECHNICON DAX(TM) SYSTEM
ClassificationAnalyzer, Chemistry, Centrifugal, For Clinical Use
Applicant TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactA Dwarica
CorrespondentA Dwarica
TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeJJG  
CFR Regulation Number862.2140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-19
Decision Date1989-03-28

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