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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K874311
Device Name MULTICHEM (R) TOTAL BILIRUBIN
Applicant
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Applicant Contact QUINCY E CRIDER
Correspondent
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Correspondent Contact QUINCY E CRIDER
Regulation Number862.1110
Classification Product Code
CIG  
Date Received10/20/1987
Decision Date 11/25/1987
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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