Devices

HEMOCUE AB GLUCOSE 201 DM ANALYZER

Model / Serial
Hb Glucose 201 DM System: (USA): Serial Numbers: 0632720008; 0651720088; 0641720017; 0651720037, 0651720087 & 0651720092; 0707720047; 0639720004; 0641720004, 0641720008,& 0641710015. Hb Glucose 201 DM System: (Euroope): Serial Numbers: 064172009; 0641720032; 0641720042, 0641720044 & 0644720026 & 0644720050; 0644720006 & 0651720002; 0644720022; 0644720039, 0644720044 & 0651720006.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.
Product Description
HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level.
Manufacturer
Hemo Cue, Inc.
1 Event
- Recall of HEMOCUE AB GLUCOSE 201 DM ANALYZER

Manufacturer

Hemo Cue, Inc.

Manufacturer Address
Hemo Cue, Inc., 11331 Valley View St, Cypress CA 90630-5366
Source
USFDA

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