PDJ — Hemoglobin A1c Test System Class II
Classification Details
- Product Code
- PDJ
- Device Class
- Class II
- Regulation Number
- 862.1373
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252749 | shanghai medconn medical technology co | Medconn 8K Glycated Hemoglobin Test System | January 6, 2026 |
| K250073 | tosoh bioscience | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | October 3, 2025 |
| K242911 | shanghai medconn medical technology co | Medconn Glycated Hemoglobin Test system | June 20, 2025 |
| K220999 | shijiazhuang hipro biotechnology co | Hipro Glycosylated Hemoglobin (HbA1c) Test System | September 12, 2024 |
| K200904 | tosoh bioscience | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | August 5, 2021 |
| K200256 | siemens healthcare diagnostics | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | July 2, 2021 |
| K193053 | roche diagnostics operations (rdo) | Tina-quant Hemoglobin A1cDx Gen.3 | March 26, 2020 |
| K182651 | beckman coulter ireland | HbA1c Advanced | January 16, 2019 |
| K182988 | alere technologies | Afinion HbA1c Dx on Afinion 2 | November 29, 2018 |
| K173909 | siemens healthcare diagnostics | Dimension Hemoglobin A1c Assay | July 13, 2018 |
| K173206 | sekisui diagnostics p.e.i | SEKURE HbA1c Assay | July 12, 2018 |
| K180296 | alere technologies | Afinion HbA1c Dx | May 7, 2018 |
| K171861 | sebia | CAPILLARYS Hb A1c | February 7, 2018 |
| K171771 | siemens healthcare diagnostics | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | December 4, 2017 |
| K171537 | sebia | CAPI 3 Hb A1c | September 12, 2017 |
| K162822 | arkray factory | ADAMS A1c HA-8180V, CALIBRATOR 80 | June 29, 2017 |
| K160571 | roche diagnostics operations (rdo) | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | December 19, 2016 |
| K161687 | bio-rad laboratories | D-10 Hemoglobin A1c Program | October 14, 2016 |
| K151321 | bio-rad laboratories | D-100 HbA1c, D-100 HbA1c Calibrator Pack | December 9, 2015 |
| K142595 | ortho clinical diagnostics | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS C | June 4, 2015 |