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FDA 510(k)

CK-NAC REAGENT

K-Number: K834502 · 1984-02-27

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1984-02-27
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-NAC REAGENT 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 1984-02-27 under 510(k) number K834502. 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?

CK-NAC REAGENT is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K834502.

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

CK-NAC REAGENT received FDA 510(k) clearance on 1984-02-27, under 510(k) number K834502.

Who is the listed applicant for CK-NAC REAGENT?

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 CK-NAC REAGENT?

The FDA product code for CK-NAC REAGENT is CGS.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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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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