CONE-TROL LIQUID CHEMISTRY CONTROLS

Multi-analyte Controls, All Kinds (assayed)

CONE BIOPRODUCTS

The following data is part of a premarket notification filed by Cone Bioproducts with the FDA for Cone-trol Liquid Chemistry Controls.

Pre-market Notification Details

Device IDK121759
510k NumberK121759
Device Name:CONE-TROL LIQUID CHEMISTRY CONTROLS
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant CONE BIOPRODUCTS 1012 N Austin St Seguin,  TX  78155
ContactWill Cone
CorrespondentWill Cone
CONE BIOPRODUCTS 1012 N Austin St Seguin,  TX  78155
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-15
Decision Date2012-07-24
Summary:summary

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