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510(k) K012474

ATAC PAK CPK REAGENT KIT by Elan Holdings, Inc. — Product Code CGS

K012474 is an FDA 510(k) premarket notification submitted by Elan Holdings, Inc. for the device "ATAC PAK CPK REAGENT KIT". The FDA issued a decision of Substantially Equivalent on October 3, 2001. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Elan Holdings, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2001
Date Received
August 2, 2001
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 Elan Holdings, Inc.

  • K013152 — ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS (November 9, 2001)
  • K010488 — ATAC PAK AST REAGENT KIT (April 9, 2001)
  • K000958 — ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS (May 24, 2000)
  • K000900 — ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS (May 2, 2000)
  • K992844 — HICHEM ISE ELECTROLYTE BUFFER (November 26, 1999)
  • K992842 — HICHEM ISE ELECTROLYTE REFERENCE (November 26, 1999)
  • K992845 — HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIB (October 18, 1999)
  • K992846 — HICHEM TOTAL PROTEIN REAGENT (October 18, 1999)
  • K992847 — HICHEM BUN REAGENT (October 14, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (July 9, 1999)

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