Medical Device Manufacturer · US , Brea , CA

Elan Diagnostics - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1999

Recent clearances: ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elan Diagnostics Chemistry ✕

13 devices

1-12 of 13

Cleared Sep 29, 2003

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR

Chemistry · 270d

Cleared Sep 26, 2003

ATAC TOTAL BILIRUBIN REAGENT

Chemistry · 267d

Cleared Mar 19, 2003

ATAC CALIBRATOR

Chemistry · 20d

Cleared Mar 13, 2003

ATAC CALCIUM REAGENT AND ATAC CALIBRATOR

Chemistry · 176d

Cleared Mar 10, 2003

ATAC PAK MAGNESIUM REAGENT

Chemistry · 67d

Cleared Mar 07, 2003

ATAC PAK ALBUMIN REAGENT

Chemistry · 64d

Cleared Mar 07, 2003

ATAC PAK PHOSPHORUS REAGENT

Chemistry · 64d

Cleared Feb 14, 2003

ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR

Chemistry · 127d

Cleared Jul 12, 2002

ATAC PAK BUN REAGENT

Chemistry · 71d

Cleared Apr 12, 2002

ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS

Chemistry · 50d

Cleared Sep 26, 2000

ATAC PAK ALP REAGENT KIT

Chemistry · 62d

Cleared May 17, 2000

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

Chemistry · 89d