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FDA 510(k)

ROCHE(R) CARDIOSCREEN-CK

K-Number: K891462 · 1989-05-22

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1989-05-22
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE(R) CARDIOSCREEN-CK is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-05-22 under 510(k) number K891462. 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 ROCHE(R) CARDIOSCREEN-CK?

ROCHE(R) CARDIOSCREEN-CK is a medical device that received FDA 510(k) clearance on 1989-05-22. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K891462.

When did ROCHE(R) CARDIOSCREEN-CK receive FDA 510(k) clearance?

ROCHE(R) CARDIOSCREEN-CK received FDA 510(k) clearance on 1989-05-22, under 510(k) number K891462.

Who is the listed applicant for ROCHE(R) CARDIOSCREEN-CK?

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

What is the FDA product code for ROCHE(R) CARDIOSCREEN-CK?

The FDA product code for ROCHE(R) CARDIOSCREEN-CK is CGS.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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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