Afinion HbA1c Dx on Afinion 2
FDA 510(k) K182988 · Alere Technologies AS
510(k) numberK182988
Submission
- Device name
- Afinion HbA1c Dx on Afinion 2
- Applicant
- Alere Technologies AS
Oslo, NO - Received
- October 29, 2018
- Decision date
- November 29, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDJ – Hemoglobin A1c Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1373
- Specialty
- Clinical Chemistry
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Other 510(k)s with product code PDJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test SystemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 01/06/2026SE |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | Tosoh Bioscience, Inc. | 10/03/2025SE |
| K242911 | Medconn Glycated Hemoglobin Test systemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 06/20/2025SE |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test SystemPDJ · Traditional | Shijiazhuang Hipro Biotechnology Co., Ltd. | 09/12/2024SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | Tosoh Bioscience, Inc. | 08/05/2021SE |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssayPDJ · Special | Siemens Healthcare Diagnostics, Inc. | 07/02/2021SE |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | Roche Diagnostics Operations (Rdo) | 03/26/2020SE |
| K182651 | HbA1c AdvancedPDJ · Traditional | Beckman Coulter Ireland, Inc. | 01/16/2019SE |
| K173909 | Dimension Hemoglobin A1c AssayPDJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2018SE |
| K173206 | SEKURE HbA1c AssayPDJ · Traditional | Sekisui Diagnostics P.E.I., Inc. | 07/12/2018SE |
More from Sekisui Diagnostics P.E.I., Inc.
Questions and answers
When was Afinion HbA1c Dx on Afinion 2 cleared by the FDA?
Afinion HbA1c Dx on Afinion 2 (K182988) received a 510(k) decision of Substantially Equivalent on November 29, 2018, 31 days after the submission was received.
What is the product code of K182988?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.