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510k Database
Manufacturers
US
Hemocue, Inc.
Medical Device Manufacturer
·
US , Potomac , MD
Hemocue, Inc. - FDA 510(k) Cleared Devices
9 submissions
·
9 cleared
·
Since 1991
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hemocue, Inc.
Hematology
✕
3
devices
1-3 of 3
Filters
Cleared
Jun 10, 2004
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
K041234
·
GKR
Hematology
·
31d
Cleared
Aug 25, 2003
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
K032203
·
GKR
Hematology
·
38d
Cleared
Sep 24, 1996
HEMOCUE B-HEMOGLOBIN SYSTEM
K961312
·
GKR
Hematology
·
173d
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9
Chemistry
6
Hematology
3