510(k) K140654
- Device
- Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K140654
- Product code
- PDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-22
- Date received
- 2014-03-14
- Regulation
- 862.1373
- Classification name
- Hemoglobin A1c Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDITH R WALLACH
- Address
- 100 Abbott Park Rd. Dept 09v6 Ap8 Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 9611444
- 8020316
- 9614673
- 9680746
- 3003539867
- 2050012
- 3005333358
- 2432235
- 3004529019
- 1319809
- 3012963943
- 1000487132
- 2250051
- 8023024
- 1319808
- 2915274
- 3002809144
- 2517506
- 9613069
- 8031673
- 2032682
- 3043654757
- 3016438761
- 1832816
- 3002642396
- 3003422726
- 3006421415
- 3005529799
- 9610126
- 2027969
- 3009448641
- 1319681
- 3000308930
- 3043149833
Source Documents#
Other 510(k) Records For Product Code PDJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test System | Shanghai Medconn Medical Technology Co., Ltd. | 2026-01-06 |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience, Inc. | 2025-10-03 |
| K242911 | Medconn Glycated Hemoglobin Test system | Shanghai Medconn Medical Technology Co., Ltd. | 2025-06-20 |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test System | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024-09-12 |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 | Tosoh Bioscience, Inc. | 2021-08-05 |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-02 |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Operations (Rdo) | 2020-03-26 |
| K182651 | HbA1c Advanced | Beckman Coulter Ireland, Inc. | 2019-01-16 |
| K182988 | Afinion HbA1c Dx on Afinion 2 | Alere Technologies AS | 2018-11-29 |
| K173909 | Dimension Hemoglobin A1c Assay | Siemens Healthcare Diagnostics, Inc. | 2018-07-13 |
| K173206 | SEKURE HbA1c Assay | Sekisui Diagnostics P.E.I., Inc. | 2018-07-12 |
| K180296 | Afinion HbA1c Dx | Alere Technologies AS | 2018-05-07 |
| K171861 | CAPILLARYS Hb A1c | Sebia | 2018-02-07 |
| K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017-12-04 |
| K171537 | CAPI 3 Hb A1c | Sebia | 2017-09-12 |
Legacy Summary#
summary
FDA Review#
Decision Summary