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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 K112101
Device Name FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
Applicant
POLYMED THERAPEUTICS, INC
27001 LA PAZ ROAD,
SUITE 266B
MISSION VIEJO,  CA  92691
Applicant Contact TERRI WALLACE
Correspondent
POLYMED THERAPEUTICS, INC
27001 LA PAZ ROAD,
SUITE 266B
MISSION VIEJO,  CA  92691
Correspondent Contact TERRI WALLACE
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/22/2011
Decision Date 07/17/2012
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
Recalls CDRH Recalls
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