BILIRUBIN CONTROL

Multi-analyte Controls, All Kinds (assayed)

PHOENIX DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Phoenix Diagnostics, Inc. with the FDA for Bilirubin Control.

Pre-market Notification Details

Device IDK902616
510k NumberK902616
Device Name:BILIRUBIN CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant PHOENIX DIAGNOSTICS, INC. 93 WEST ST. Medfield,  MA  02052
ContactPam Nunna
CorrespondentPam Nunna
PHOENIX DIAGNOSTICS, INC. 93 WEST ST. Medfield,  MA  02052
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-13
Decision Date1990-07-19

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