ST AIA-PACK BNP Assay— 510(k) K211199

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K211199 for ST AIA-PACK BNP Assay, Substantially Equivalent on 2021-11-08. Applicant: Tosoh Bioscience, Inc..

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code NBC
Advisory panel: Clinical Chemistry
Date received: 2021-04-22
Decision date: 2021-11-08
Decision: Substantially Equivalent
Clearance type: Special
Location: South San Franciso, CA, US

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