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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 K772157
Device Name CREATININE, 64972
Applicant
Harleco
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Harleco
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1225
Classification Product Code
CGX  
Date Received11/16/1977
Decision Date 12/06/1977
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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