HBA1C LINEARITY SET

Single (specified) Analyte Controls (assayed And Unassayed)

CONE BIOPRODUCTS

The following data is part of a premarket notification filed by Cone Bioproducts with the FDA for Hba1c Linearity Set.

Pre-market Notification Details

Device IDK052010
510k NumberK052010
Device Name:HBA1C LINEARITY SET
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant CONE BIOPRODUCTS 1008 N. RIVER ST. Seguin,  TX  78155
ContactWilliam Cone
CorrespondentWilliam Cone
CONE BIOPRODUCTS 1008 N. RIVER ST. Seguin,  TX  78155
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-25
Decision Date2005-10-04
Summary:summary

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