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510(k) K962247

HICHEM CK/NAC REAGENT KIT by Elan Pharma, Inc. — Product Code CGS

K962247 is an FDA 510(k) premarket notification submitted by Elan Pharma, Inc. for the device "HICHEM CK/NAC REAGENT KIT". The FDA issued a decision of Substantially Equivalent on August 15, 1996. 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 Pharma, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1996
Date Received
June 11, 1996
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 Pharma, Inc.

  • K982469 — HICHEM CHOLESTEROL REAGENT KIT (August 19, 1998)
  • K981769 — HICHEM PHOSPHORUS REAGENT KIT (June 29, 1998)
  • K960115 — HICHEM BUN/UREA REAGENT KIT (March 29, 1996)

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