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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 K011952
Device Name DRUGS OF ABUSE MULTI-TEST STRIP
Applicant
Microdiagnostics, Inc.
28062 Forbes Rd., Suite B
Laguna Niguel,  CA  92677
Applicant Contact JUNE SHOZI
Correspondent
Microdiagnostics, Inc.
28062 Forbes Rd., Suite B
Laguna Niguel,  CA  92677
Correspondent Contact JUNE SHOZI
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJD   LCM   LDJ  
Date Received06/21/2001
Decision Date 10/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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