K192380 is an FDA 510(k) clearance for the ST AIA-PACK BNP. This device is classified as a Test, Natriuretic Peptide (Class II - Special Controls, product code NBC).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on August 24, 2020, 360 days after receiving the submission on August 30, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1117.
| 510(k) Number | K192380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2019 |
| Decision Date | August 24, 2020 |
| Days to Decision | 360 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBC — Test, Natriuretic Peptide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1117 |