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FDA 510(k)

CREATINE KINASE (CK)

K-Number: K972155 · 1997-07-17

ApplicantStanbio Laboratory
Decision Date1997-07-17
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATINE KINASE (CK) is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1997-07-17 under 510(k) number K972155. 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)?

CREATINE KINASE (CK) is a medical device that received FDA 510(k) clearance on 1997-07-17. The listed applicant is Stanbio Laboratory. The 510(k) number is K972155.

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

CREATINE KINASE (CK) received FDA 510(k) clearance on 1997-07-17, under 510(k) number K972155.

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

The FDA 510(k) record lists Stanbio Laboratory as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050283CREATININE LIQUICOLORK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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