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510(k) K112416

CPK REAGENT by Vital Diagnostics (Manufacturing) Ptyltd — Product Code CGS

K112416 is an FDA 510(k) premarket notification submitted by Vital Diagnostics (Manufacturing) Ptyltd for the device "CPK REAGENT". The FDA issued a decision of Substantially Equivalent on November 9, 2011. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Vital Diagnostics (Manufacturing) Ptyltd has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2011
Date Received
August 22, 2011
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 Vital Diagnostics (Manufacturing) Ptyltd

  • K120626 — EON CALCIUM REGENT (August 22, 2012)
  • K111063 — VITAL SERUM CONTROLS (June 28, 2011)
  • K110394 — ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) (June 9, 2011)
  • K100060 — EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77 (December 15, 2010)

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)
  • 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)
  • K043202 — OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 (December 23, 2004)

FDA data resources