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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 K873467
Device Name QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
Applicant
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Applicant Contact JOHNSON, III
Correspondent
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Correspondent Contact JOHNSON, III
Regulation Number862.3280
Classification Product Code
DIF  
Date Received08/28/1987
Decision Date 09/29/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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