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FDA 510(k)

CREATINE KINASE (CK-NAC)

K-Number: K013912 · 2002-01-18

ApplicantJas Diagnostics, Inc.
Decision Date2002-01-18
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE (CK-NAC) is the device name listed in this FDA 510(k) record. The listed applicant is Jas Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K013912. 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 CREATINE KINASE (CK-NAC)?

CREATINE KINASE (CK-NAC) is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Jas Diagnostics, Inc.. The 510(k) number is K013912.

When did CREATINE KINASE (CK-NAC) receive FDA 510(k) clearance?

CREATINE KINASE (CK-NAC) received FDA 510(k) clearance on 2002-01-18, under 510(k) number K013912.

Who is the listed applicant for CREATINE KINASE (CK-NAC)?

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

What is the FDA product code for CREATINE KINASE (CK-NAC)?

The FDA product code for CREATINE KINASE (CK-NAC) is CGS.

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Other records listing Jas Diagnostics, 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.

K080623CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NAK080618DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUIDK022519LDL CHOLESTEROL (AUTOMATED)K021671JAS HDL CHOLESTEROL (AUTOMATED) REAGENTK020454CHEMISTRY CALIBRATORK020282JAS AMYLASE LIQUID REAGENT

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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 DXK182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) PtyltdK083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics

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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