Medical Device Manufacturer · US , Lake Forest , CA

Hemocue AB - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2006

Recent clearances: HemoCue Hb 301 System, HemoCue Hb 801 System, HEMOCUE WBC SYSTEM

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hemocue AB Chemistry ✕

2 devices

1-2 of 2

Cleared Sep 06, 2006

HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT...

Chemistry · 169d

Cleared Feb 17, 2006

HEMOCUE ALBUMIN 201 ANALYZING SYSTEM

Chemistry · 88d