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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, Opiates
510(k) Number K973761
Device Name MICRO-STRIP FOR OPIATE 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 Number862.3650
Classification Product Code
DJG  
Date Received10/02/1997
Decision Date 12/24/1997
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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