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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K872310
Device Name CURAD MEDICATED PLASTIC STRIPS
Applicant
The Kendal Co.
One Federal St.
Boston,  MA  02110
Applicant Contact MARK W WENZEL
Correspondent
The Kendal Co.
One Federal St.
Boston,  MA  02110
Correspondent Contact MARK W WENZEL
Regulation Number862.1225
Classification Product Code
CGX  
Date Received06/15/1987
Decision Date 08/28/1987
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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