TMC I, II

Multi-analyte Controls, All Kinds (assayed)

CIBA CORNING DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Tmc I, Ii.

Pre-market Notification Details

Device IDK930534
510k NumberK930534
Device Name:TMC I, II
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole,  MA  02032
ContactRonald D Schaefer
CorrespondentRonald D Schaefer
CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole,  MA  02032
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-02
Decision Date1994-04-04

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