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510(k) K931326

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1993
Date Received
March 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.

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  • K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED (August 25, 1993)
  • K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (August 16, 1993)
  • K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT (November 2, 1992)
  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (October 13, 1992)
  • K922921 — KING DIAGNOSTICS CHLORIDE REAGENT (October 5, 1992)
  • K923927 — KING DIAGNOSTICS MAGNESIUM REAGENT (September 30, 1992)
  • K923128 — KING DIAGNOSTICS CHOLESTEROL REAGENT (September 9, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (September 9, 1992)
  • K922964 — KING DIAGNOSTIC TRIGLYCERIDES REAGENT (August 18, 1992)

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  • K062737 — CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (June 12, 2007)
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