FDA Product Code
FDA Product Code PDJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1373
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260468 | H100Plus Hemoglobin Testing System | Shenzhen Lifotronic Technology Co., Ltd. | 2026-10-02 | Traditional | PDF ↗ |
| K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | 2026-01-06 | Traditional | PDF ↗ |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | 2025-10-03 | Traditional | PDF ↗ |
| K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | 2025-06-20 | Traditional | PDF ↗ |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024-09-12 | Traditional | PDF ↗ |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2021-08-05 | Traditional | PDF ↗ |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-02 | Special | PDF ↗ |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Operations (Rdo) | 2020-03-26 | Traditional | PDF ↗ |
| K182651 | HbA1c Advanced | Beckman Coulter Ireland, Inc. | 2019-01-16 | Traditional | PDF ↗ |
| K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | 2018-11-29 | Special | PDF ↗ |
| K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics, Inc. | 2018-07-13 | Traditional | PDF ↗ |
| K173206 | SEKURE HbA1c Assay | Sekisui Diagnostics P.E.I., Inc. | 2018-07-12 | Traditional | PDF ↗ |
| K180296 | Afinion HbA1c Dx | Alere Technologies AS | 2018-05-07 | Traditional | PDF ↗ |
| K171861 | CAPILLARYS Hb A1c | Sebia | 2018-02-07 | Traditional | PDF ↗ |
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017-12-04 | Traditional | PDF ↗ |
| K171537 | CAPI 3 Hb A1c | Sebia | 2017-09-12 | Traditional | PDF ↗ |
| K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | Arkray Factory, Inc. | 2017-06-29 | Traditional | PDF ↗ |
| K160571 | cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay | Roche Diagnostics Operations (Rdo) | 2016-12-19 | Traditional | PDF ↗ |
| K161687 | D-10 Hemoglobin A1c Program | Bio-Rad Laboratories, Inc. | 2016-10-14 | Traditional | PDF ↗ |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories, Inc. | 2015-12-09 | Traditional | PDF ↗ |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II | Ortho Clinical Diagnostics | 2015-06-04 | Traditional | PDF ↗ |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | Abbott Laboratories | 2015-05-22 | Traditional | PDF ↗ |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | Bio-Rad Laboratories, Inc. | 2015-03-24 | Traditional | PDF ↗ |
| K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS | Abbott Laboratories | 2014-02-28 | Traditional | PDF ↗ |
| K131580 | AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 | Tosoh Bioscience, Inc. | 2014-01-23 | Traditional | PDF ↗ |
| K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY | Roche Diagnostics Operations | 2013-08-08 | Traditional | PDF ↗ |
| DEN130002 | TINA-QUANT HBA1C GEN. 2 TEST SYSTEM | Roche Diagnostics | 2013-05-23 | Post-NSE | — |
Product code PDJ · Class II · Clinical Chemistry. Data: openFDA.