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OTC - Over The Counter

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Document NumberK100051
Test Name Jant Pharmacal AccutestDrug of Abuse Urine (Cassette) Test  
Manufacturer NameALFA SCIENTIFIC DESIGNS, INC.
Consumer Information Phone Number(800)676-5565
Test TypeOxycodone
Effective Date06/17/2011
Device Classification Name enzyme immunoassay, opiates
510(k) Number K100051
Device Name INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
Applicant
ALFA SCIENTIFIC DESIGNS, INC.
13200 GREGG ST.
POWAY,  CA  92064
Applicant Contact NASISHU WANG
Correspondent
ALFA SCIENTIFIC DESIGNS, INC.
13200 GREGG ST.
POWAY,  CA  92064
Correspondent Contact NASISHU WANG
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
NGI  
Date Received01/08/2010
Decision Date 07/06/2010
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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