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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K121065
Device Name POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
Applicant
Polymed Therapeutics, Inc.
12828 Doe Ln.
Gaithersburg,  MD  20878
Applicant Contact JJ XIA
Correspondent
Polymed Therapeutics, Inc.
12828 Doe Ln.
Gaithersburg,  MD  20878
Correspondent Contact JJ XIA
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJC   DNK   JXM   LCM  
LDJ  
Date Received04/06/2012
Decision Date 05/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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