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FDA 510(k)

OLYMPUS CREATINE KINASE REAGENT OSR6179/6279

K-Number: K994189 · 2000-01-20

ApplicantOlympus Diagnostica GmbH
Decision Date2000-01-20
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Diagnostica GmbH. It received FDA 510(k) clearance on 2000-01-20 under 510(k) number K994189. 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 OLYMPUS CREATINE KINASE REAGENT OSR6179/6279?

OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 is a medical device that received FDA 510(k) clearance on 2000-01-20. The listed applicant is Olympus Diagnostica GmbH. The 510(k) number is K994189.

When did OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 receive FDA 510(k) clearance?

OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 received FDA 510(k) clearance on 2000-01-20, under 510(k) number K994189.

Who is the listed applicant for OLYMPUS CREATINE KINASE REAGENT OSR6179/6279?

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

What is the FDA product code for OLYMPUS CREATINE KINASE REAGENT OSR6179/6279?

The FDA product code for OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 is CGS.

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Other records listing Olympus Diagnostica GmbH 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.

K984145OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENTK981854OLYMPUS SERUM PROTEIN MULTICALIBRATOR,K982035OLYMPUS CALCIUM ARSENAZO III REAGENT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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