VITROS CHEMISTRY PRODUCTS UPRO SLIDES

Lowry (colorimetric), Total Protein

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 Vitros Chemistry Products Upro Slides.

Pre-market Notification Details

Device IDK964960
510k NumberK964960
Device Name:VITROS CHEMISTRY PRODUCTS UPRO SLIDES
ClassificationLowry (colorimetric), Total Protein
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 CodeJGP  
Subsequent Product CodeJIT
Subsequent Product CodeJJY
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-11
Decision Date1997-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750000630 K964960 000
10758750000623 K964960 000

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