ST AIA-PACK BNP— 510(k) K192380
Substantially EquivalentFujirebio Diagnostics,Inc.
FDA 510(k) clearance K192380 for ST AIA-PACK BNP, Substantially Equivalent on 2020-08-24. Applicant: Fujirebio Diagnostics,Inc..
Clearance details
- Applicant
- Fujirebio Diagnostics,Inc.
- Product code
- Code NBC
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.