Medical Device Manufacturer · US , Brea , CA

Elan Holdings, Inc.

12 submissions · 12 cleared · Since 1999
12
Total
12
Cleared
0
Denied

Elan Holdings, Inc. — FDA 510(k) Submissions

Elan Holdings, Inc. has submitted 12 FDA 510(k) premarket notifications since 1999, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Ion Specific, Sodium, Enzymatic Esterase--oxidase, Cholesterol, Urease And Glutamic Dehydrogenase, Urea Nitrogen, Nadh Oxidation/nad Reduction, Ast/sgot, Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
K013152 · LBS Ldl & Vldl Precipitation,... · Chemistry
Nov 2001 50d
ATAC PAK CPK REAGENT KIT
K012474 · CGS Nad Reduction/nadh... · Chemistry
Oct 2001 62d
ATAC PAK AST REAGENT KIT
K010488 · CIT Nadh Oxidation/nad... · Chemistry
Apr 2001 48d
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
K000958 · CDQ Urease And Glutamic... · Chemistry
May 2000 61d
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
K000900 · CHH Enzymatic... · Chemistry
May 2000 42d
HICHEM ISE ELECTROLYTE REFERENCE
K992842 · JGS Electrode, Ion Specific,... · Chemistry
Nov 1999 94d
HICHEM ISE ELECTROLYTE BUFFER
K992844 · JGS Electrode, Ion Specific,... · Chemistry
Nov 1999 94d
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
K992845 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 1999 55d
HICHEM TOTAL PROTEIN REAGENT
K992846 · CEK Biuret (colorimetric),... · Chemistry
Oct 1999 55d
HICHEM BUN REAGENT
K992847 · LFP Conductivity Rate, Urea... · Chemistry
Oct 1999 51d
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K991789 · LBR Ldl & Vldl Precipitation,... · Chemistry
Jul 1999 45d
ELAN ALKALINE PHOSPHATE REAGENT KIT
K991387 · CJE Nitrophenylphosphate,... · Chemistry
May 1999 28d
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