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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. Open, Classified |
PDJ | K200256 |
| Mar 27, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E);
Siemens Material Number (SMN): 11097536; Open, Classified |
PDJ | K200256 |
| May 24, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood.
Product Code Open, Classified |
PDJ | K142595 |
| Jun 9, 2022 | Abbott Laboratories REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL Open, Classified |
PDJ | None listed |
| Jun 9, 2022 | Abbott Laboratories REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL Open, Classified |
PDJ | K130255 |
| Jun 9, 2022 | Abbott Laboratories REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL Open, Classified |
PDJ | K130255 K140654 |
| Feb 9, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536 Open, Classified |
PDJ | K171771 |
| Mar 23, 2020 | Abbott Diagnostics Technologies AS Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 11 Open, Classified |
PDJ | K180296 K182988 |
| Nov 11, 2016 | Roche Diagnostics Operations, Inc. COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test
Catalog number 04528123160 Terminated |
PDJ | None listed |
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