Medical Device Manufacturer · US , Brea , CA

Elan Diagnostics - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1999

Total

Cleared

Denied

Elan Diagnostics has 13 FDA 510(k) cleared chemistry devices. Based in Brea, US.

Historical record: 13 cleared submissions from 1999 to 2003.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

Elan Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Elan Diagnostics

13 devices

1-12 of 13

Cleared Sep 29, 2003

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR

K030003 · CIG

Chemistry · 270d

Cleared Sep 26, 2003

ATAC TOTAL BILIRUBIN REAGENT

ATAC CALCIUM REAGENT AND ATAC CALIBRATOR

K023105 · CIC

Chemistry · 176d

Cleared Mar 10, 2003

ATAC PAK MAGNESIUM REAGENT

K030010 · JGJ

Chemistry · 67d

Cleared Mar 07, 2003

ATAC PAK ALBUMIN REAGENT

K030006 · CIX

Chemistry · 64d

Cleared Mar 07, 2003

ATAC PAK PHOSPHORUS REAGENT

K030015 · CEO

Chemistry · 64d

Cleared Feb 14, 2003

ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR

ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS

K020575 · MRR

Chemistry · 50d

Cleared Sep 26, 2000

ATAC PAK ALP REAGENT KIT

K002285 · CJE

Chemistry · 62d

Cleared May 17, 2000

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

K000556 · CFR

Chemistry · 89d

Elan Diagnostics - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Elan Diagnostics

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