FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER

Kit, Test, Pregnancy, Hcg, Over The Counter

POLYMED THERAPEUTICS, INC

The following data is part of a premarket notification filed by Polymed Therapeutics, Inc with the FDA for Fastep At-home Pregnancy, Hcg, Over The Counter.

Pre-market Notification Details

Device IDK122907
510k NumberK122907
Device Name:FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
ClassificationKit, Test, Pregnancy, Hcg, Over The Counter
Applicant POLYMED THERAPEUTICS, INC 27001 LA PAZ ROAD, SUITE 266B Mission Viejo,  CA  92691
ContactTerri Wallace
CorrespondentTerri Wallace
POLYMED THERAPEUTICS, INC 27001 LA PAZ ROAD, SUITE 266B Mission Viejo,  CA  92691
Product CodeLCX  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-21
Decision Date2013-03-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10722066005146 K122907 000
00722066005323 K122907 000

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