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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name visual, pregnancy hcg, prescription use
510(k) Number K132834
Device Name FASTEP S10 HCG SERUM/URINE COMBO TEST
Applicant
POLYMED THERAPEUTICS, INC
12828 DOE LANE
GAITHERSBURG,  MD  20878
Applicant Contact J.J XIA
Correspondent
POLYMED THERAPEUTICS, INC
12828 DOE LANE
GAITHERSBURG,  MD  20878
Correspondent Contact J.J XIA
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/10/2013
Decision Date 01/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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