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510k Database
Manufacturers
US
Hemagen Diagnostics, Inc.
Medical Device Manufacturer
·
US , Waltham , MA
Hemagen Diagnostics, Inc. - FDA 510(k) Cleared Devices
52 submissions
·
52 cleared
·
Since 1986
Official Website
52
Total
52
Cleared
0
Denied
52
devices
51-52 of 52
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1
2
3
Cleared
Aug 19, 1986
SERATEST ENA [SS-B] KIT
K862700
·
LLL
Immunology
·
35d
Cleared
Apr 22, 1986
SERATEST RF (HEMAGGLUTINATION) KIT
K855221
·
DHR
Immunology
·
113d
1
2
3
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52
Immunology
35
Chemistry
15
Microbiology
2