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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2018-07-12 under 510(k) 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. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K173206.

When did SEKURE HbA1c Assay receive FDA 510(k) clearance?

SEKURE HbA1c Assay received FDA 510(k) clearance on 2018-07-12, under 510(k) number K173206.

Who is the listed applicant for SEKURE HbA1c Assay?

The FDA 510(k) record lists Sekisui Diagnostics P.E.I., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEKURE HbA1c Assay?

The FDA product code for SEKURE HbA1c Assay is PDJ.

Other records listing Sekisui Diagnostics P.E.I., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: PDJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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