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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 K881856
Device Name BIOTROL CREATININE H.P. REAGENT
Applicant
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1225
Classification Product Code
CGX  
Date Received05/03/1988
Decision Date 06/16/1988
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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