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510(k) K811746

KING DIAGNOSTICS CHOLESTEROL-FE TEST by King Diagnostics, Inc. — Product Code CHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cyclic Amp
Device Class
Class II
Regulation Number
862.1230
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)
  • K931326 — KING DIAGNOSTICS CK REAGENT (June 15, 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)

Other clearances for product code CHO

  • K860253 — AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) (March 14, 1986)
  • K844135 — PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU (March 5, 1985)
  • K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (June 14, 1984)
  • K823504 — CYCLIC ADENOSINE MONOPHOSHATE BY RADIO (January 28, 1983)
  • K811273 — CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] (May 27, 1981)