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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K873011
Device Name QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
Applicant
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Applicant Contact ERNEST S JOHNSON
Correspondent
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Correspondent Contact ERNEST S JOHNSON
Regulation Number862.3280
Classification Product Code
LAS  
Date Received08/04/1987
Decision Date 10/29/1987
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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