Disposable Blood Lancet

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

SteriLance Medical (Suzhou) Inc.

The following data is part of a premarket notification filed by Sterilance Medical (suzhou) Inc. with the FDA for Disposable Blood Lancet.

Pre-market Notification Details

Device IDK221507
510k NumberK221507
Device Name:Disposable Blood Lancet
ClassificationSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Applicant SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District Suzhou,  CN 215153
ContactSusan Sun
CorrespondentSusan Sun
SteriLance Medical (Suzhou) Inc. No.168 PuTuoShan Road, New District Suzhou,  CN 215153
Product CodeQRK  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-23
Decision Date2022-08-31

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