Automated Gylcohemoglobin Analyzer HLC-723G8
FDA 510(k) K131580 · Tosoh Bioscience, Inc.
510(k) numberK131580
Submission
- Device name
- Automated Gylcohemoglobin Analyzer HLC-723G8
- Applicant
- Tosoh Bioscience, Inc.
South San Franciso, CA, US - Received
- May 31, 2013
- Decision date
- January 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDJ – Hemoglobin A1c Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1373
- Specialty
- Clinical Chemistry
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Other 510(k)s with product code PDJ
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|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test SystemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 01/06/2026SE |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | Tosoh Bioscience, Inc. | 10/03/2025SE |
| K242911 | Medconn Glycated Hemoglobin Test systemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 06/20/2025SE |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test SystemPDJ · Traditional | Shijiazhuang Hipro Biotechnology Co., Ltd. | 09/12/2024SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | Tosoh Bioscience, Inc. | 08/05/2021SE |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssayPDJ · Special | Siemens Healthcare Diagnostics, Inc. | 07/02/2021SE |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | Roche Diagnostics Operations (Rdo) | 03/26/2020SE |
| K182651 | HbA1c AdvancedPDJ · Traditional | Beckman Coulter Ireland, Inc. | 01/16/2019SE |
| K182988 | Afinion HbA1c Dx on Afinion 2PDJ · Special | Alere Technologies AS | 11/29/2018SE |
| K173909 | Dimension Hemoglobin A1c AssayPDJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2018SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | 10/03/2025SE |
| K211199 | ST AIA-PACK BNP AssayNBC · Special | 11/08/2021SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | 08/05/2021SE |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | 02/17/2016SE |
| K153417 | ST AIA-PACK PROG III Calibrator SetJIT · Traditional | 12/18/2015SE |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH…MRG · Traditional | 10/26/2015SE |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ · Traditional | 07/02/2015SE |
| K143296 | AIA-PACK C-Peptide Control SetJJX · Traditional | 12/16/2014SE |
| K143144 | ST AIA-PACK PROG II Calibrator SetJIT · Traditional | 12/03/2014SE |
| K140648 | ST Aia-Pack C-Peptide II Calibrator SetJIT · Abbreviated | 04/10/2014SE |
Questions and answers
When was Automated Gylcohemoglobin Analyzer HLC-723G8 cleared by the FDA?
Automated Gylcohemoglobin Analyzer HLC-723G8 (K131580) received a 510(k) decision of Substantially Equivalent on January 23, 2014, 237 days after the submission was received.
What is the product code of K131580?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.