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Manufacturers
US
Healgen Scientific, LLC
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Medical Device Manufacturer
·
US , Houston , TX
Healgen Scientific, LLC - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 2012
Official Website
27
Total
27
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Apr 10, 2013
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY...
K123703
·
LCX
Chemistry
·
128d
Cleared
Apr 17, 2012
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR...
K111999
·
JIO
Chemistry
·
279d
1
2
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27
Toxicology
14
Chemistry
10
Microbiology
3