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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K070251
Device Name CARBON DIOXIDE LIQUID STABLE REAGENT
Applicant
Pointe Scientific, Inc.,
5449 Research Dr.
Lincoln Park,  MI  48188
Applicant Contact WILLIAM F WALTERS, JR
Correspondent
Pointe Scientific, Inc.,
5449 Research Dr.
Lincoln Park,  MI  48188
Correspondent Contact WILLIAM F WALTERS, JR
Regulation Number862.1160
Classification Product Code
KHS  
Date Received01/26/2007
Decision Date 04/30/2007
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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