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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 K863388
Device Name QUANTIMETRIX DRUG FREE SERUM 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 Number862.3280
Classification Product Code
DIF  
Date Received09/03/1986
Decision Date 09/29/1986
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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