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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 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 2019-04-17 under 510(k) 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. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K182702.

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

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

Who is the listed applicant for SEKURE Creatine Kinase 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 Creatine Kinase Assay?

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

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.

K202644AcetaminophenK180835SEKURE Acetaminophen L3K AssayK173206SEKURE HbA1c AssayK163078DC-UIBC-CAL

Related Devices (Code: CGS)

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.

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.

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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