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510(k) K993741

EZ LDL CHOLESTEROL TEST SYSTEM by Sigma Diagnostics, Inc. — Product Code MRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2000
Date Received
November 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Low Density, Lipoprotein
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (November 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (October 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (March 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (March 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)

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  • K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (August 3, 2009)
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  • K063841 — NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS (July 23, 2008)
  • K051121 — DIRECT LDL CHOLESTEROL, MODEL L530-60H (August 8, 2005)
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  • K041720 — VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND P (August 25, 2004)