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510(k) K931326

KING DIAGNOSTICS CK REAGENT by King Diagnostics, Inc. — Product Code CGS

K931326 is an FDA 510(k) premarket notification submitted by King Diagnostics, Inc. for the device "KING DIAGNOSTICS CK REAGENT". The FDA issued a decision of Substantially Equivalent on Jun 15, 1993. The device falls under product code CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. King Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 15, 1993
Date Received
Mar 16, 1993
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 King Diagnostics, Inc.

  • K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (Oct 22, 1993)
  • K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED (Aug 25, 1993)
  • K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (Aug 16, 1993)
  • K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT (Nov 2, 1992)
  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (Oct 13, 1992)
  • K922921 — KING DIAGNOSTICS CHLORIDE REAGENT (Oct 5, 1992)
  • K923927 — KING DIAGNOSTICS MAGNESIUM REAGENT (Sep 30, 1992)
  • K923128 — KING DIAGNOSTICS CHOLESTEROL REAGENT (Sep 9, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (Sep 9, 1992)
  • K922964 — KING DIAGNOSTIC TRIGLYCERIDES REAGENT (Aug 18, 1992)

Other clearances for product code CGS

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

FDA data resources