Medical Device Manufacturer · US , Brea , CA

Elan Holdings, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1999

Recent clearances: ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS, ATAC PAK CPK REAGENT KIT, ATAC PAK AST REAGENT KIT

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elan Holdings, Inc. Chemistry ✕

12 devices

1-12 of 12

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