SEKURE HbA1c Assay
K-Number: K173206 · 2018-07-12
ApplicantSekisui Diagnostics P.E.I., Inc.
Decision Date2018-07-12
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
SEKURE HbA1c Assay is a medical device manufactured by Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2018-07-12 under approval number K173206. 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 SEKURE HbA1c Assay?
SEKURE HbA1c Assay is a medical device that received FDA 510(k) clearance on 2018-07-12. It is manufactured by Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K173206.
When was SEKURE HbA1c Assay approved by the FDA?
SEKURE HbA1c Assay received FDA 510(k) clearance on 2018-07-12, under approval number K173206.
What company makes SEKURE HbA1c Assay?
SEKURE HbA1c Assay is manufactured by Sekisui Diagnostics P.E.I., Inc..
What is the FDA product code for SEKURE HbA1c Assay?
The FDA product code for SEKURE HbA1c Assay is PDJ.
Other Devices by Sekisui Diagnostics P.E.I., 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.