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510(k) K991789

ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS by Elan Holdings, Inc. — Product Code LBR

K991789 is an FDA 510(k) premarket notification submitted by Elan Holdings, Inc. for the device "ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS". The FDA issued a decision of Substantially Equivalent on July 9, 1999. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Elan Holdings, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1999
Date Received
May 25, 1999
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 Elan Holdings, Inc.

  • K013152 — ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS (November 9, 2001)
  • K012474 — ATAC PAK CPK REAGENT KIT (October 3, 2001)
  • K010488 — ATAC PAK AST REAGENT KIT (April 9, 2001)
  • K000958 — ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS (May 24, 2000)
  • K000900 — ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS (May 2, 2000)
  • K992844 — HICHEM ISE ELECTROLYTE BUFFER (November 26, 1999)
  • K992842 — HICHEM ISE ELECTROLYTE REFERENCE (November 26, 1999)
  • K992845 — HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIB (October 18, 1999)
  • K992846 — HICHEM TOTAL PROTEIN REAGENT (October 18, 1999)
  • K992847 — HICHEM BUN REAGENT (October 14, 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)
  • K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (May 28, 1999)
  • K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (January 28, 1999)
  • K980772 — HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (April 27, 1998)

FDA data resources