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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 K932304
Device Name MICRO EIA FOR AMPHETAMINE METABOLITES
Applicant
Microdiagnostics, Inc.
28062 Forbes Rd., Suite B
Laguna Niguel,  CA  92677
Applicant Contact ROY CHUNG
Correspondent
Microdiagnostics, Inc.
28062 Forbes Rd., Suite B
Laguna Niguel,  CA  92677
Correspondent Contact ROY CHUNG
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received05/12/1993
Decision Date 12/07/1993
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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