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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 K994438
Device Name BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
Applicant
SPECTRX, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact JAMES R VEALE
Correspondent
SPECTRX, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact JAMES R VEALE
Regulation Number862.1113
Classification Product Code
MQM  
Date Received12/30/1999
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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