Elan Holdings, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HICHEM ISE ELECTROLYTE REFERENCE, HICHEM ISE ELECTROLYTE BUFFER, HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elan Holdings, Inc. Chemistry ✕
12 devices
Cleared
Nov 09, 2001
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
Chemistry
50d
Cleared
Oct 03, 2001
ATAC PAK CPK REAGENT KIT
Chemistry
62d
Cleared
Apr 09, 2001
ATAC PAK AST REAGENT KIT
Chemistry
48d
Cleared
May 24, 2000
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
Chemistry
61d
Cleared
May 02, 2000
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
Chemistry
42d
Cleared
Nov 26, 1999
HICHEM ISE ELECTROLYTE REFERENCE
Chemistry
94d
Cleared
Nov 26, 1999
HICHEM ISE ELECTROLYTE BUFFER
Chemistry
94d
Cleared
Oct 18, 1999
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT,...
Chemistry
55d
Cleared
Oct 18, 1999
HICHEM TOTAL PROTEIN REAGENT
Chemistry
55d
Cleared
Oct 14, 1999
HICHEM BUN REAGENT
Chemistry
51d
Cleared
Jul 09, 1999
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
Chemistry
45d
Cleared
May 19, 1999
ELAN ALKALINE PHOSPHATE REAGENT KIT
Chemistry
28d