TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS

Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use

TECHNICON INSTRUMENTS CORP.

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

Pre-market Notification Details

Device IDK870998
510k NumberK870998
Device Name:TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS
ClassificationAnalyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Applicant TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactLeonard A Dwarica
CorrespondentLeonard A Dwarica
TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeJJC  
CFR Regulation Number862.2150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-11
Decision Date1987-05-26

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