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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hemoglobin
510(k) Number K032791
Device Name GLYCOHEMOSURE HBA1C CONTROL
Applicant
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Applicant Contact GEBHARD NEYER
Correspondent
Quantimetrix Corp.
2005 Manhattan Beach Blvd.
Redondo Beach,  CA  90278
Correspondent Contact GEBHARD NEYER
Regulation Number864.8625
Classification Product Code
GGM  
Date Received09/08/2003
Decision Date 10/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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