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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 K854180
Device Name IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN
Applicant
Clinical Data, Inc.
1172 Commonwealth Ave.
Boston,  MA  02134
Applicant Contact ISRAEL M STEIN
Correspondent
Clinical Data, Inc.
1172 Commonwealth Ave.
Boston,  MA  02134
Correspondent Contact ISRAEL M STEIN
Regulation Number862.1110
Classification Product Code
CIG  
Date Received10/15/1985
Decision Date 11/25/1985
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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