VS-SENSE TEST

Dye-indicator, Ph (urinary, Non-quantitative)

COMMON SENSE, LTD.

The following data is part of a premarket notification filed by Common Sense, Ltd. with the FDA for Vs-sense Test.

Pre-market Notification Details

Device IDK091287
510k NumberK091287
Device Name:VS-SENSE TEST
ClassificationDye-indicator, Ph (urinary, Non-quantitative)
Applicant COMMON SENSE, LTD. 777 6TH STREET NW SUITE 1100 Washington,  DC  20001
ContactNatasha Leskovsek
CorrespondentNatasha Leskovsek
COMMON SENSE, LTD. 777 6TH STREET NW SUITE 1100 Washington,  DC  20001
Product CodeCEN  
CFR Regulation Number862.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-01
Decision Date2009-08-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290006558183 K091287 000
07290006558176 K091287 000
07290006558169 K091287 000

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