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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K861420
Device Name QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL
Applicant
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250
Applicant Contact JOHNSON, III
Correspondent
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250
Correspondent Contact JOHNSON, III
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/15/1986
Decision Date 09/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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