Panels › Clinical Chemistry › Product code PDJ · Class 2
Hemoglobin A1c Test System
Regulation 862.1373
2510(k)s in 12 months (27 all time)
2recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in PDJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics, Inc. | 3 | 3 |
| Abbott Laboratories | 2 | 3 |
| Bio-Rad Laboratories, Inc. | 3 | 0 |
| Tosoh Bioscience, Inc. | 3 | 0 |
| Alere Technologies AS | 2 | 0 |
| Ortho Clinical Diagnostics | 1 | 1 |
| Roche Diagnostics Operations | 1 | 1 |
| Roche Diagnostics Operations (Rdo) | 2 | 0 |
| Sebia | 2 | 0 |
| Shanghai Medconn Medical Technology Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2026 | K260468 | H100Plus Hemoglobin Testing System Shenzhen Lifotronic Technology Co., Ltd., CN | PDJ |
| Jan 6, 2026 | K252749 | Medconn 8K Glycated Hemoglobin Test System Shanghai Medconn Medical Technology Co., Ltd., CN | PDJ |
| Oct 3, 2025 | K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 Tosoh Bioscience, Inc. | PDJ |
| Jun 20, 2025 | K242911 | Medconn Glycated Hemoglobin Test system Shanghai Medconn Medical Technology Co., Ltd., CN | PDJ |
| Sep 12, 2024 | K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System Shijiazhuang Hipro Biotechnology Co., Ltd., CN | PDJ |
| Aug 5, 2021 | K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 Tosoh Bioscience, Inc. | PDJ |
| Jul 2, 2021 | K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay Siemens Healthcare Diagnostics, Inc. | PDJ |
| Mar 26, 2020 | K193053 | Tina-quant Hemoglobin A1cDx Gen.3 Roche Diagnostics Operations (Rdo) | PDJ |
| Jan 16, 2019 | K182651 | HbA1c Advanced Beckman Coulter Ireland, Inc., IE | PDJ |
| Nov 29, 2018 | K182988 | Afinion HbA1c Dx on Afinion 2 Alere Technologies AS, NO | PDJ |
| Jul 13, 2018 | K173909 | Dimension Hemoglobin A1c Assay Siemens Healthcare Diagnostics, Inc. | PDJ |
| Jul 12, 2018 | K173206 | SEKURE HbA1c Assay Sekisui Diagnostics P.E.I., Inc., CA | PDJ |
| May 7, 2018 | K180296 | Afinion HbA1c Dx Alere Technologies AS, NO | PDJ |
| Feb 7, 2018 | K171861 | CAPILLARYS Hb A1c Sebia | PDJ |
| Dec 4, 2017 | K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay Siemens Healthcare Diagnostics, Inc. | PDJ |
| Sep 12, 2017 | K171537 | CAPI 3 Hb A1c Sebia | PDJ |
| Jun 29, 2017 | K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 Arkray Factory, Inc., JP | PDJ |
| Dec 19, 2016 | K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay Roche Diagnostics Operations (Rdo) | PDJ |
| Oct 14, 2016 | K161687 | D-10 Hemoglobin A1c Program Bio-Rad Laboratories, Inc. | PDJ |
| Dec 9, 2015 | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack Bio-Rad Laboratories, Inc. | PDJ |
| Jun 4, 2015 | K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verif Ortho Clinical Diagnostics | PDJ |
| May 22, 2015 | K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls Abbott Laboratories | PDJ |
| Mar 24, 2015 | K142448 | VARIANT II TURBO HbA1c Kit - 2.0 Bio-Rad Laboratories, Inc. | PDJ |
| Feb 28, 2014 | K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS Abbott Laboratories | PDJ |
| Jan 23, 2014 | K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 Tosoh Bioscience, Inc. | PDJ |
| Aug 8, 2013 | K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY Roche Diagnostics Operations | PDJ |
| May 23, 2013 | DEN130002 | TINA-QUANT HBA1C GEN. 2 TEST SYSTEM Roche Diagnostics | PDJ |
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