EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN

Colorimetry, Acetaminophen

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 For Acetaminophen.

Pre-market Notification Details

Device IDK954933
510k NumberK954933
Device Name:EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
ClassificationColorimetry, Acetaminophen
Applicant JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
ContactYvonne E Middlefell
CorrespondentYvonne E Middlefell
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
Product CodeLDP  
CFR Regulation Number862.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-27
Decision Date1995-12-18

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