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510(k) K984107

RDI DIRECT LDL CHOLESTEROL TEST by Reference Diagnostics, Inc. — Product Code MRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1999
Date Received
November 17, 1998
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

Other clearances by Reference Diagnostics, Inc.

  • K053211 — RDI HSFERRITIN KIT (March 13, 2006)
  • K053291 — FERRITIN CALIBRATOR SET, CATALOG NO. 8203 (March 13, 2006)
  • K052148 — TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET (November 9, 2005)
  • K030044 — EXTENDED RANGE HS CRP KIT, CAT NO:9200 (September 30, 2003)
  • K030772 — RDI EXTENDED RANGE CRP CALIBRATOR SET (April 11, 2003)
  • K021607 — RDI HS CRP CALIBRATOR SET (June 27, 2002)
  • K021609 — RDI HS CRP KIT (June 27, 2002)
  • K000783 — DIRECT TIBC CALIBRATOR (May 4, 2000)
  • K000781 — DIRECT TIBC KIT (May 2, 2000)
  • K990216 — MAGNETIC TIBC KIT (February 16, 1999)

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  • K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (August 3, 2009)
  • K090734 — EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROL (July 17, 2009)
  • K063841 — NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS (July 23, 2008)
  • K051121 — DIRECT LDL CHOLESTEROL, MODEL L530-60H (August 8, 2005)
  • K043264 — LDL-EX SEIKEN ASSAY KIT (January 26, 2005)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)
  • K041720 — VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND P (August 25, 2004)