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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
510(k) Number K864168
Device Name MORPHINE ROCHE (R) EIA TEST
Applicant
Roche Diagnostic Systems, Inc.
Div. Of Hoffmann-La Roche, Inc
Nutley,  NJ  07110
Applicant Contact GRIFFIN FITZGERALD
Correspondent
Roche Diagnostic Systems, Inc.
Div. Of Hoffmann-La Roche, Inc
Nutley,  NJ  07110
Correspondent Contact GRIFFIN FITZGERALD
Regulation Number862.3640
Classification Product Code
DOE  
Date Received10/24/1986
Decision Date 03/16/1987
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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