Medical Device Manufacturer · US , San Diego , CA

General Atomics - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2003

Recent clearances: DIAZYME LP(A) ASSAY, DIAZYME APOLIPOPROTEIN A-1 ASSAY, DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

View 6 510(k) Devices ↓ Official Website

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - General Atomics Chemistry ✕

6 devices

1-6 of 6

Cleared Jan 13, 2009

DIAZYME LP(A) ASSAY

Chemistry · 138d

Cleared Jul 16, 2008

DIAZYME APOLIPOPROTEIN A-1 ASSAY

Chemistry · 268d

Cleared Jan 22, 2008

DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

Chemistry · 137d

Cleared Jun 28, 2005

HBA1C ENZYMATIC ASSAY

Chemistry · 153d

Cleared Oct 29, 2004

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

Chemistry · 50d

Cleared Dec 23, 2003

DIAZYME LITHIUM ENZYMATIC ASSAY KIT

Chemistry · 63d