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Document NumberK063545/A001
Test Name Alfa Scientific Designs, Inc. Multi-Drug of Abuse Urine Test  
Manufacturer NameALFA SCIENTIFIC DESIGNS, INC.
Consumer Information Phone Number1(877)204-5071
Test TypeMethadone
Effective Date06/28/2007
Device Classification Name enzyme immunoassay, opiates
510(k) Number K063545
Device Name MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
Applicant
ALFA SCIENTIFIC DESIGNS, INC.
13200 GREGG ST.
POWAY,  CA  92064
Applicant Contact DAITING RONG
Correspondent
ALFA SCIENTIFIC DESIGNS, INC.
13200 GREGG ST.
POWAY,  CA  92064
Correspondent Contact DAITING RONG
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DJC   DJR   DKZ  
JXM   LCM   LDJ   LFG   NFV  
Date Received11/24/2006
Decision Date 05/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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