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FDA 510(k) Application Details - K211199
Device Classification Name
Test,Natriuretic Peptide
More FDA Info for this Device
510(K) Number
K211199
Device Name
Test,Natriuretic Peptide
Applicant
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Francisco, CA 94080 US
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Contact
Louise Musante
Other 510(k) Applications for this Contact
Regulation Number
862.1117
More FDA Info for this Regulation Number
Classification Product Code
NBC
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More FDA Info for this Product Code
Date Received
04/22/2021
Decision Date
11/08/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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