Identifiers
- 510(k) Number
- K192380 FDA 510(k)
- FDA Product Code
- NBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1117 FDA 510(k)
- Regulation Number
- 862.1117 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The St Aia-Pack Bnp is a Test, Natriuretic Peptide, classified as a device in the Clinical Chemistry medical specialty. It is a device with a product code of NBC and a device class of 2. The device is used in the field of Clinical Chemistry.
The St Aia-Pack Bnp is supplied by Fujirebio Diagnostics, Inc. and has received FDA 510K clearance under the number K192380. The device is regulated under regulation number 862.1117 and has a review advisory committee of CH. The decision description for the device is Substantially Equivalent, with a decision date of 2020-08-24 and a date received of 2019-08-30.
Frequently asked questions
What is the St Aia-Pack Bnp used for?
The St Aia-Pack Bnp is used in the field of Clinical Chemistry as a test for natriuretic peptide.
What is the regulatory status of the St Aia-Pack Bnp?
The St Aia-Pack Bnp has received FDA 510K clearance under the number K192380 and is regulated under regulation number 862.1117.
What type of device is the St Aia-Pack Bnp?
The St Aia-Pack Bnp is classified as a device in the Clinical Chemistry medical specialty with a product code of NBC and a device class of 2.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ST AIA-PACK BNP (K192380) — FDA 510 (k) | Innolitics, 510 (k) K192380 — ST AIA-PACK BNP — RegDataLab, ST AIA-PACK BNP 510 (k) K192380 - FDA.report, ST AIA-PACK BNP — FDA 510 (k) K192380 | MedTracker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192380 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujirebio Diagnostics, Inc.
- FDA Applicant
- Fujirebio Diagnostics,Inc.
Sources (1)
- FDA 510(k) K192380 24 fields · synced Sep 24, 2026