SEMEN ANALYSIS KIT

Semen Analysis Device

Humagen FERTILITY DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Humagen Fertility Diagnostics, Inc. with the FDA for Semen Analysis Kit.

Pre-market Notification Details

Device IDK915229
510k NumberK915229
Device Name:SEMEN ANALYSIS KIT
ClassificationSemen Analysis Device
Applicant Humagen FERTILITY DIAGNOSTICS, INC. 2345 HUNTER'S WAY #2 Charlottesville,  VA  22901
ContactDebra Bryant
CorrespondentDebra Bryant
Humagen FERTILITY DIAGNOSTICS, INC. 2345 HUNTER'S WAY #2 Charlottesville,  VA  22901
Product CodePOV  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-20
Decision Date1994-08-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60888937900028 K915229 000
60888937900011 K915229 000
20888937911033 K915229 000

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