Bionote, Inc.
⚠️ Moderate Risk
FEI: 3010847152 • Gyeonggi-do • SOUTH KOREA
FEI Number
3010847152
Location
Gyeonggi-do
Country
SOUTH KOREAAddress
22, Samsung 1-Ro 4-Gil, Hwaseong-Si,, , Gyeonggi-do, , South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/23/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/16/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/16/2020 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 10/9/2020 | 83OTGNON-SARS CORONAVIRUS MULTIPLEX NUCLEIC ACID ASSAY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Bionote, Inc.'s FDA import refusal history?
Bionote, Inc. (FEI: 3010847152) has 4 FDA import refusal record(s) in our database, spanning from 10/9/2020 to 11/23/2020.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Bionote, Inc.'s FEI number is 3010847152.
What types of violations has Bionote, Inc. received?
Bionote, Inc. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Bionote, Inc. come from?
All FDA import refusal data for Bionote, Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.