EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE

Azo Dye, Calcium

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 Calcium (ca) Slide.

Pre-market Notification Details

Device IDK961226
510k NumberK961226
Device Name:EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
ClassificationAzo Dye, Calcium
Applicant JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
ContactCharles C Morganson
CorrespondentCharles C Morganson
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
Product CodeCJY  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-29
Decision Date1996-05-07

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