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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 K070207
Device Name MULTI-ANALYTE CHEMISTRY CALIBRATOR
Applicant
Pointe Scientific, Inc.,
5449 Research Dr.
Lincoln Park,  MI  48188
Applicant Contact RON JAMISON
Correspondent
Pointe Scientific, Inc.,
5449 Research Dr.
Lincoln Park,  MI  48188
Correspondent Contact RON JAMISON
Regulation Number862.1150
Classification Product Code
JIX  
Date Received01/22/2007
Decision Date 04/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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