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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 K881241
Device Name TOTAL BILIRUBIN REAGENT
Applicant
Tech-Neal Scientific, Inc.
5410 S. Kilpatrick Ave.
Chicago,  IL  60632
Applicant Contact ARUN SANGHAVI
Correspondent
Tech-Neal Scientific, Inc.
5410 S. Kilpatrick Ave.
Chicago,  IL  60632
Correspondent Contact ARUN SANGHAVI
Regulation Number862.1110
Classification Product Code
CIG  
Date Received03/22/1988
Decision Date 05/27/1988
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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