Submission Details
| 510(k) Number | K211199 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 22, 2021 |
| Decision Date | November 08, 2021 |
| Days to Decision | 200 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
ST AIA-PACK BNP Assay
Nov 2021
Decision
200d
Days
Class 2
Risk
About This 510(k) Submission
K211199 is an FDA 510(k) clearance for the ST AIA-PACK BNP Assay, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on November 8, 2021, 200 days after receiving the submission on April 22, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.
Device Classification
| Product Code | NBC — Test, Natriuretic Peptide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1117 |
Manufacturer
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