Medical Device Manufacturer · US , San Diego , CA

Axis Biochemicals, Asa - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1998

Recent clearances: MODIFICATION TO IMX HOMOCYSTEINE, AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY, IMX HOMOCYSTEINE

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Axis Biochemicals, Asa Chemistry ✕

3 devices

1-3 of 3

Cleared Oct 06, 1999

MODIFICATION TO IMX HOMOCYSTEINE

Chemistry · 92d

Cleared Oct 16, 1998

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY

Chemistry · 220d

Cleared Oct 01, 1998

IMX HOMOCYSTEINE

Chemistry · 212d