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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K061377
Device Name APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
Applicant
Pointe Scientific, Inc.,
5449 Research Dr.
Lincoln Park,  MI  48188
Applicant Contact WILLIAM WALTERS
Correspondent
Pointe Scientific, Inc.,
5449 Research Dr.
Lincoln Park,  MI  48188
Correspondent Contact WILLIAM WALTERS
Regulation Number862.1475
Classification Product Code
MSJ  
Subsequent Product Code
JIT  
Date Received05/17/2006
Decision Date 03/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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