FDA 510(k)

CK-NAC REAGENT

K-Number: K974833 · 1998-02-13

Decision Date1998-02-13

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 Intersect Systems, Inc.. It received FDA 510(k) clearance on 1998-02-13 under 510(k) number K974833. 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 1998-02-13. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K974833.

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

CK-NAC REAGENT received FDA 510(k) clearance on 1998-02-13, under 510(k) number K974833.

Who is the listed applicant for CK-NAC REAGENT?

The FDA 510(k) record lists Intersect 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 Intersect Systems, Inc. as applicant

K021636ALBUMIN REAGENT K011972DIRECT BILIRUBIN REAGENT K011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT K003892TOTAL BILIRUBIN REAGENT K983937DUAL VIAL CREATININE REAGENT K941807INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT

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Related Devices (Code: CGS)

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DX K182702SEKURE 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) Ptyltd K083465DIMENSION 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.