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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K902616
Device Name BILIRUBIN CONTROL
Applicant
Phoenix Diagnostics, Inc.
93 W. St.
Medfield,  MA  02052
Applicant Contact PAM NUNNA
Correspondent
Phoenix Diagnostics, Inc.
93 W. St.
Medfield,  MA  02052
Correspondent Contact PAM NUNNA
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/13/1990
Decision Date 07/19/1990
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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