Facet Blood Lancets

Multiple Use Blood Lancet For Single Patient Use Only

Facet Technologies LLC

The following data is part of a premarket notification filed by Facet Technologies Llc with the FDA for Facet Blood Lancets.

Pre-market Notification Details

Device IDK222539
510k NumberK222539
Device Name:Facet Blood Lancets
ClassificationMultiple Use Blood Lancet For Single Patient Use Only
Applicant Facet Technologies LLC 3900 N. Commerce Dr. Atlanta,  GA  30344
ContactJames Bonds
CorrespondentJames Bonds
Facet Technologies LLC 3900 N. Commerce Dr. Atlanta,  GA  30344
Product CodeQRL  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-22
Decision Date2022-11-18

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