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FDA 510(k)

CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)

K-Number: K864359 · 1987-02-06

ApplicantTrace Scientific , Ltd.
Decision Date1987-02-06
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1987-02-06 under 510(k) number K864359. 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 CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)?

CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) is a medical device that received FDA 510(k) clearance on 1987-02-06. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K864359.

When did CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) receive FDA 510(k) clearance?

CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) received FDA 510(k) clearance on 1987-02-06, under 510(k) number K864359.

Who is the listed applicant for CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)?

The FDA product code for CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) is CGS.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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