CAPILLARYS Hb A1c
K-Number: K171861 · 2018-02-07
ApplicantSebia
Decision Date2018-02-07
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
CAPILLARYS Hb A1c is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2018-02-07 under approval number K171861. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CAPILLARYS Hb A1c?
CAPILLARYS Hb A1c is a medical device that received FDA 510(k) clearance on 2018-02-07. It is manufactured by Sebia. The 510(k) number is K171861.
When was CAPILLARYS Hb A1c approved by the FDA?
CAPILLARYS Hb A1c received FDA 510(k) clearance on 2018-02-07, under approval number K171861.
What company makes CAPILLARYS Hb A1c?
CAPILLARYS Hb A1c is manufactured by Sebia.
What is the FDA product code for CAPILLARYS Hb A1c?
The FDA product code for CAPILLARYS Hb A1c is PDJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.