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510(k) K972155

CREATINE KINASE (CK) by Stanbio Laboratory — Product Code CGS

K972155 is an FDA 510(k) premarket notification submitted by Stanbio Laboratory for the device "CREATINE KINASE (CK)". The FDA issued a decision of Substantially Equivalent on July 17, 1997. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Stanbio Laboratory has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1997
Date Received
June 5, 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 Stanbio Laboratory

  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)
  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (July 18, 2008)
  • K050283 — CREATININE LIQUICOLOR (June 30, 2005)
  • K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (June 30, 2005)
  • K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (March 14, 2005)
  • K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (October 14, 2004)
  • K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIB (March 12, 2004)
  • K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (March 10, 2004)
  • K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (October 24, 2003)
  • K020378 — QUPID PLUS E.R. (June 21, 2002)

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)

FDA data resources