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510k Database
Manufacturers
US
Hygeia Sciences
Medical Device Manufacturer
·
US , Newton , MA
Hygeia Sciences - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1986
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hygeia Sciences
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 10, 1988
HYGEIA URINE PREGNANCY TEST
K882192
·
DHA
Chemistry
·
169d
Cleared
Jul 02, 1986
HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY
K862083
·
JHJ
Chemistry
·
30d
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4
Chemistry
2
Microbiology
2