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510(k) K911906

MAGNETIC HDL CHOLESTEROL TEST by Reference Diagnostics, Inc. — Product Code LBR

K911906 is an FDA 510(k) premarket notification submitted by Reference Diagnostics, Inc. for the device "MAGNETIC HDL CHOLESTEROL TEST". The FDA issued a decision of Substantially Equivalent on July 18, 1991. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Reference Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1991
Date Received
April 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Hdl
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)
  • K021609 — RDI HS CRP KIT (June 27, 2002)
  • K021607 — RDI HS CRP CALIBRATOR SET (June 27, 2002)
  • K000783 — DIRECT TIBC CALIBRATOR (May 4, 2000)
  • K000781 — DIRECT TIBC KIT (May 2, 2000)
  • K990216 — MAGNETIC TIBC KIT (February 16, 1999)

Other clearances for product code LBR

  • K143691 — LDLC3 LDL-Cholesterol Gen.3 (January 28, 2015)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (January 22, 2008)
  • K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (July 26, 2005)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRO (August 30, 2001)
  • K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (August 12, 1999)
  • K992002 — AUTOHDL CHOLESTEROL REAGENT SET (August 5, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (July 9, 1999)
  • K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (May 28, 1999)
  • K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (January 28, 1999)

FDA data resources