Clinical Chemistry · 7 clearances · 5 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Shanghai Medconn Medical Technology Co., Ltd. | 2 | 1 | 2026-01-06 |
| Tosoh Bioscience, Inc. | 2 | 1 | 2025-10-03 |
| Roche Diagnostics Operations (Rdo) | 1 | 0 | 2020-03-26 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 0 | 2021-07-02 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | 1 | 0 | 2024-09-12 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 83036 | CPT | — | High | Hemoglobin A1c (HbA1c) quantitation; standard CPT for diabetes diagnostic testing |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-01-06 | K252749 | Shanghai Medconn Medical Technology Co., Ltd. | Medconn 8K Glycated Hemoglobin Test System |
| 2025-10-03 | K250073 | Tosoh Bioscience, Inc. | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 |
| 2025-06-20 | K242911 | Shanghai Medconn Medical Technology Co., Ltd. | Medconn Glycated Hemoglobin Test system |
| 2024-09-12 | K220999 | Shijiazhuang Hipro Biotechnology Co., Ltd. | Hipro Glycosylated Hemoglobin (HbA1c) Test System |
| 2021-08-05 | K200904 | Tosoh Bioscience, Inc. | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 |
| 2021-07-02 | K200256 | Siemens Healthcare Diagnostics, Inc. | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay |
| 2020-03-26 | K193053 | Roche Diagnostics Operations (Rdo) | Tina-quant Hemoglobin A1cDx Gen.3 |