510(k) K192380

Device
ST AIA-PACK BNP
Applicant
Fujirebio Diagnostics,Inc.
510(k) number
K192380
Product code
NBC
Decision
Substantially Equivalent (SESE)
Decision date
2020-08-24
Date received
2019-08-30
Regulation
862.1117
Classification name
Test, Natriuretic Peptide
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Stacey Dolan
Address
201 Great Valley Pkwy. Malvern PA US 19355 19355

FDA Registration Numbers

Source Documents

510(k) summary PDF

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