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510k Database
Manufacturers
US
Hybritech, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Hybritech, Inc. - FDA 510(k) Cleared Devices
63 submissions
·
63 cleared
·
Since 1981
63
Total
63
Cleared
0
Denied
53
devices
51-53 of 53
Filters
1
2
3
Cleared
Oct 13, 1981
TANDEM QUALITATIVE HCG KIT
K812461
·
JHI
Chemistry
·
43d
Cleared
Sep 01, 1981
TANDEM PAP KIT - (PARTS I & II)
K811959
·
JFH
Chemistry
·
54d
Cleared
May 29, 1981
TAN DEM* - IGE KIT
K802913
·
DGC
Chemistry
·
192d
1
2
3
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63
Chemistry
53
Immunology
6
Microbiology
4