MICROLET NEXT Lancing Device, MICROLET Lancet

Multiple Use Blood Lancet For Single Patient Use Only

Ascensia Diabetes Care US Inc

The following data is part of a premarket notification filed by Ascensia Diabetes Care Us Inc with the FDA for Microlet Next Lancing Device, Microlet Lancet.

Pre-market Notification Details

Device IDK220633
510k NumberK220633
Device Name:MICROLET NEXT Lancing Device, MICROLET Lancet
ClassificationMultiple Use Blood Lancet For Single Patient Use Only
Applicant Ascensia Diabetes Care US Inc 5 Wood Hollow Road Parsippany,  NJ  07054
ContactSangram Yadav
CorrespondentSangram Yadav
Ascensia Diabetes Care US Inc 5 Wood Hollow Road Parsippany,  NJ  07054
Product CodeQRL  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-04
Decision Date2022-06-03

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