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510(k) K100550

POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC by Polymedco, Inc. — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2010
Date Received
February 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Polymedco, Inc.

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  • K111143 — POLY-CHEM 90 TOTAL BILIRUBIN (September 1, 2011)
  • K090703 — POLY-CHEM 90 GLUCOSE (October 20, 2009)
  • K061944 — POLY-CHEM CREATININE (November 3, 2006)
  • K053553 — NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL (March 9, 2006)
  • K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST (October 21, 2004)
  • K041297 — POLYMEDCO OC LIGHT FOBT TEST (August 12, 2004)
  • K033706 — POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS (February 4, 2004)
  • K023654 — GLYCA-DIRECT FRUCTOSAMINE (May 2, 2003)

Other clearances for product code LBS

  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES (September 7, 2012)
  • K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER (September 27, 2011)
  • K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL (August 31, 2011)
  • K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (July 12, 2011)
  • K100010 — HDL CHOLESTEROL (HDLX) ASSAY (May 14, 2010)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)
  • K073497 — HDL CHOLESTEROL REAGENT, MODEL 10211 (April 14, 2008)