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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bilirubin (Total And Unbound) In The Neonate Test System
510(k) Number K001687
Device Name COLORMATE TLC BILITEST SYSTEM
Applicant
Chromatics Color Sciences Intl., Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Applicant Contact THOMAS M TSAKERIS
Correspondent
Chromatics Color Sciences Intl., Inc.
16809 Briardale Rd.
Rockville,  MD  20855
Correspondent Contact THOMAS M TSAKERIS
Regulation Number862.1113
Classification Product Code
MQM  
Date Received06/01/2000
Decision Date 09/13/2001
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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