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510(k) K912499

KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST by King Diagnostics, Inc. — Product Code CHH

K912499 is an FDA 510(k) premarket notification submitted by King Diagnostics, Inc. for the device "KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST". The FDA issued a decision of Substantially Equivalent on September 27, 1991. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. King Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1991
Date Received
June 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

Other clearances by King Diagnostics, Inc.

  • K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (October 22, 1993)
  • 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)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (September 9, 1992)
  • K923128 — KING DIAGNOSTICS CHOLESTEROL REAGENT (September 9, 1992)

Other clearances for product code CHH

  • K251091 — Lipids (December 30, 2025)
  • K232404 — CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (August 9, 2024)
  • K203597 — Cholesterol2 (June 30, 2022)
  • K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides (March 27, 2019)
  • K181373 — Extended Lipid Panel Assay (October 18, 2018)
  • K180504 — Mission Lipid Panel Monitoring System (March 28, 2018)
  • K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (July 11, 2017)
  • K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test Sys (December 22, 2016)
  • K150654 — Cholesterol (September 29, 2015)
  • K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (March 21, 2014)

FDA data resources