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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 K920018
Device Name ACCUSCREEN ASSAY
Applicant
Jk Research
1550 Cottonwood Cir.
Auburn,  CA  95603
Applicant Contact PAUL C STAHL
Correspondent
Jk Research
1550 Cottonwood Cir.
Auburn,  CA  95603
Correspondent Contact PAUL C STAHL
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received01/02/1992
Decision Date 03/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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