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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 K873365
Device Name CREATININE REAGENT
Applicant
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact MATHEW MADAPPALLY
Correspondent
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact MATHEW MADAPPALLY
Regulation Number862.1225
Classification Product Code
CGX  
Date Received08/21/1987
Decision Date 10/02/1987
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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