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FDA 510(k)

SEKURE Creatine Kinase Assay

K-Number: K182702 · 2019-04-17

ApplicantSekisui Diagnostics P.E.I., Inc.
Decision Date2019-04-17
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SEKURE Creatine Kinase Assay is a medical device manufactured by Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2019-04-17 under approval number K182702. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEKURE Creatine Kinase Assay?

SEKURE Creatine Kinase Assay is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K182702.

When was SEKURE Creatine Kinase Assay approved by the FDA?

SEKURE Creatine Kinase Assay received FDA 510(k) clearance on 2019-04-17, under approval number K182702.

What company makes SEKURE Creatine Kinase Assay?

SEKURE Creatine Kinase Assay is manufactured by Sekisui Diagnostics P.E.I., Inc..

What is the FDA product code for SEKURE Creatine Kinase Assay?

The FDA product code for SEKURE Creatine Kinase Assay is CGS.

Other Devices by Sekisui Diagnostics P.E.I., Inc.

K163078DC-UIBC-CAL K173206SEKURE HbA1c Assay K180835SEKURE Acetaminophen L3K Assay K202644Acetaminophen

Related Devices (Code: CGS)

K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc. K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DX

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.

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