CAPI 3 Hb A1c
K-Number: K171537 · 2017-09-12
ApplicantSebia
Decision Date2017-09-12
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
CAPI 3 Hb A1c is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2017-09-12 under approval number K171537. 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 CAPI 3 Hb A1c?
CAPI 3 Hb A1c is a medical device that received FDA 510(k) clearance on 2017-09-12. It is manufactured by Sebia. The 510(k) number is K171537.
When was CAPI 3 Hb A1c approved by the FDA?
CAPI 3 Hb A1c received FDA 510(k) clearance on 2017-09-12, under approval number K171537.
What company makes CAPI 3 Hb A1c?
CAPI 3 Hb A1c is manufactured by Sebia.
What is the FDA product code for CAPI 3 Hb A1c?
The FDA product code for CAPI 3 Hb A1c is PDJ.
Other Devices by Sebia
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K162822ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc.
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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.