Medical Device Manufacturer · US , Irvine , CA

First Medical, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1998

Recent clearances: ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - First Medical, Inc. Chemistry ✕

4 devices

1-4 of 4

Cleared Dec 18, 2001

MODIFICATION TO ALPHA DX SYSTEM

Chemistry · 12d

Cleared Oct 15, 2001

MODIFICATION TO ALPHA DX SYSTEM

Chemistry · 27d

Cleared Mar 13, 2001

ALPHA DX SYSTEM

Chemistry · 15d

Cleared Feb 04, 1998

ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT...

Chemistry · 42d