BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS

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 Blood Gas/electrolyte/co-oximeter Controls.

Pre-market Notification Details

Device IDK902095
510k NumberK902095
Device Name:BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant PHOENIX DIAGNOSTICS, INC. 93 WEST ST. Medfield,  MA  02052
ContactRam Nunna
CorrespondentRam 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 Received1990-05-08
Decision Date1990-06-12

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