510(k) K211199

Device
ST AIA-PACK BNP Assay
Applicant
Tosoh Bioscience, Inc.
510(k) number
K211199
Product code
NBC
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-08
Date received
2021-04-22
Regulation
862.1117
Classification name
Test, Natriuretic Peptide
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Louise Musante
Address
6000 Shoreline Ct., Suite 101 South San Franciso CA US 94080 94080

FDA Registration Numbers

Source Documents

510(k) summary PDF

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