ST AIA-PACK BNP Assay— 510(k) K211199
Substantially EquivalentTosoh Bioscience, Inc.
FDA 510(k) clearance K211199 for ST AIA-PACK BNP Assay, Substantially Equivalent on 2021-11-08. Applicant: Tosoh Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Bioscience, Inc.
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South San Franciso, CA, US
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