ST AIA-PACK BNP— 510(k) K192380

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K192380 for ST AIA-PACK BNP, Substantially Equivalent on 2020-08-24. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code NBC
Device class: Class 2
Regulation: 21 CFR 862.1117
Advisory panel: Clinical Chemistry
Date received: 2019-08-30
Decision date: 2020-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.