Medical Device Manufacturer · US , Lake Forest , CA

Hemocue AB - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2006
6
Total
6
Cleared
0
Denied

FDA 510(k) cleared devices by Hemocue AB Hematology ✕

4 devices
1-4 of 4
Cleared Aug 04, 2020
HemoCue Hb 301 System
K201217 · GKR
Hematology · 90d
Cleared Feb 01, 2019
HemoCue Hb 801 System
K181751 · GKR
Hematology · 214d
Cleared Oct 25, 2007
HEMOCUE WBC SYSTEM
K071652 · GKL
Hematology · 129d
Cleared Jun 08, 2006
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
K061047 · GKR
Hematology · 55d
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