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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 K855079
Device Name NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
EM DIAGNOSTIC SYSTEMS, INC.
480 DEMOCRAT RD.
GIBBSTOWN,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number862.1110
Classification Product Code
CIG  
Date Received12/19/1985
Decision Date 03/05/1986
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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