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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K895778
Device Name QUANTIMETRIX BILIRUBIN CALIBRATORS
Applicant
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Applicant Contact P TARBURTON,PHD
Correspondent
Quantimetrix Medical Industries
11953 S. Prairie Ave.
Hawthorne,  CA  90250
Correspondent Contact P TARBURTON,PHD
Regulation Number862.1150
Classification Product Code
JIS  
Date Received09/27/1989
Decision Date 11/14/1989
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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