EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)

Electrode, Ion Specific, Sodium

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Ektachem Clinical Chemistry Slide Sodium (na+).

Pre-market Notification Details

Device IDK961099
510k NumberK961099
Device Name:EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
ClassificationElectrode, Ion Specific, Sodium
Applicant JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
ContactCharles C Morganson, Jr.
CorrespondentCharles C Morganson, Jr.
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
Product CodeJGS  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-19
Decision Date1996-05-07

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