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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K843818
Device Name HUMAN SERUM ANTICONVULSANT DRUG CONTROL
Applicant
Quantimetrix Corp.
11953 Sourth Prairie Ave
Hawthorne,  CA  90250
Applicant Contact ARTHUR F WELLS
Correspondent
Quantimetrix Corp.
11953 Sourth Prairie Ave
Hawthorne,  CA  90250
Correspondent Contact ARTHUR F WELLS
Regulation Number862.3280
Classification Product Code
DIF  
Date Received09/28/1984
Decision Date 10/30/1984
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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