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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 K900173
Device Name HYCOR ACCUPINCH MORPHINE TEST
Applicant
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Applicant Contact RON HOOVER
Correspondent
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Correspondent Contact RON HOOVER
Regulation Number862.3650
Classification Product Code
DJG  
Date Received01/12/1990
Decision Date 03/30/1990
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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