Home / 510(k) Clearances / K974833

510(k) K974833

CK-NAC REAGENT by Intersect Systems, Inc. — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1998
Date Received
December 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Intersect Systems, Inc.

  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K011972 — DIRECT BILIRUBIN REAGENT (August 27, 2001)
  • K011692 — HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT (July 25, 2001)
  • K003892 — TOTAL BILIRUBIN REAGENT (February 20, 2001)
  • K983937 — DUAL VIAL CREATININE REAGENT (January 6, 1999)
  • K941807 — INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (September 14, 1994)
  • K932888 — INTERSECT SYSTEMS DIRECT AMYLASE REAGENT (January 31, 1994)
  • K934039 — INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET (November 16, 1993)
  • K932267 — ENZYMATIC CO2 REAGENT, MODIFICATION (September 24, 1993)
  • K913225 — URINE/CSF MICROPROTEIN REAGENT (October 11, 1991)

Other clearances for product code CGS

  • K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set (August 11, 2020)
  • K182702 — SEKURE Creatine Kinase Assay (April 17, 2019)
  • K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrato (September 7, 2016)
  • K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR (November 21, 2013)
  • K112416 — CPK REAGENT (November 9, 2011)
  • K083465 — DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREAT (February 27, 2009)
  • K081731 — DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND (August 29, 2008)
  • K072548 — CREATINE KINASE LIQUID REAGENT, MODEL C519-440 (April 18, 2008)
  • K062737 — CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (June 12, 2007)
  • K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (January 31, 2006)