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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K932623
Device Name QUANTIMETRIX BLOOD GLUCOSE CONTROLS
Applicant
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250
Applicant Contact JOHN P TARBURTON
Correspondent
Quantimetrix Corp.
4955 W. 145 St.
Hawthorne,  CA  90250
Correspondent Contact JOHN P TARBURTON
Regulation Number862.1150
Classification Product Code
JIX  
Date Received06/01/1993
Decision Date 12/09/1993
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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