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FDA 510(k) Application Details - K071100
Device Classification Name
Dye-Indicator, Ph (Urinary, Non-Quant.)
More FDA Info for this Device
510(K) Number
K071100
Device Name
Dye-Indicator, Ph (Urinary, Non-Quant.)
Applicant
COMMON SENSE, LTD.
1717 RHODE ISLAND AVE., NW
WASHINGTON, DC 20036-3001 US
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Contact
NATASHA LESKOVSEK
Other 510(k) Applications for this Contact
Regulation Number
862.1550
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Classification Product Code
CEN
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More FDA Info for this Product Code
Date Received
04/19/2007
Decision Date
10/15/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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