510(k) K230937
- Device
- Alinity i Total ß-hCG Reagent Kit, GLP systems Track
- Applicant
- Abbott Laboratories
- 510(k) number
- K230937
- Product code
- DHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-05
- Date received
- 2023-04-03
- Regulation
- 862.1155
- Classification name
- System, Test, Human Chorionic Gonadotropin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Melissa Vaughan
- Address
- 1915 Hurd Dr. Iriving TX US 75038 75038
FDA Registration Numbers
- 9610126
- 3004434309
- 1219913
- 3002809144
- 3042471840
- 2020726
- 2122870
- 3023268435
- 1649661
- 1415939
- 2250051
- 2432235
- 2032682
- 2517506
- 9680746
- 3017125176
- 1036362
- 9610240
- 2246703
- 3000308930
- 3023322455
- 2032839
- 3005094123
- 3016244760
- 3002806944
- 3006479639
- 3002642396
- 3004635103
- 3005333358
- 3007111389
- 3011522054
- 3012963943
- 3007606081
- 1319681
- 3008344661
- 3006198300
- 3004192065
- 3002637618
- 3017019647
- 3016438761
- 3005643513
- 3010825766
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DHA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | 2024-05-08 |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | 2023-12-11 |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | Abbott Laboratories | 2023-05-19 |
| K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | 2022-12-27 |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | Diazyme Laboratories, Inc. | 2021-12-13 |
| K203227 | Elecsys HCG STAT | Roche Diagnostics | 2021-08-18 |
| K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 |
| K192547 | MAGLUMI 2000 HCG/ß-HCG | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 |
| K192790 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | 2017-10-23 |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test System | Diazyme Laboratories | 2017-08-18 |
| K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials | Abbott Point of Care, Inc. | 2015-04-16 |
| K130020 | ACCESS TOTAL BHCG (5TH IS) | Beckman Coulter, Inc. | 2013-10-01 |
| K131037 | LIAISON XL HCG | DiaSorin, Inc. | 2013-09-06 |
| K072500 | ONE STEP HCG URINE/SERUM TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 |