Accu-Chek FastClix Blood Lancing System

Multiple Use Blood Lancet For Single Patient Use Only

Roche Diabetes Care, Inc

The following data is part of a premarket notification filed by Roche Diabetes Care, Inc with the FDA for Accu-chek Fastclix Blood Lancing System.

Pre-market Notification Details

Device IDK220608
510k NumberK220608
Device Name:Accu-Chek FastClix Blood Lancing System
ClassificationMultiple Use Blood Lancet For Single Patient Use Only
Applicant Roche Diabetes Care, Inc 9115 Hague Road Indianapolis,  IN  46250
ContactThomas Kristen
CorrespondentThomas Kristen
Roche Diabetes Care, Inc 9115 Hague Road Indianapolis,  IN  46250
Product CodeQRL  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-02
Decision Date2022-04-29

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.