DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT

Single (specified) Analyte Controls (assayed And Unassayed)

DREW SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Drew Scientific Ltd. with the FDA for Drew Scientific Glycated Hemoglobin Five Level Linearity Kit.

Pre-market Notification Details

Device IDK060510
510k NumberK060510
Device Name:DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant DREW SCIENTIFIC LTD. SOWERBY WOODS BUSINESS PARK PARK ROAD Barrow In Furness Cumbria,  GB La14 4qr
ContactDiane Hill
CorrespondentDiane Hill
DREW SCIENTIFIC LTD. SOWERBY WOODS BUSINESS PARK PARK ROAD Barrow In Furness Cumbria,  GB La14 4qr
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-27
Decision Date2006-06-19

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