MAGLUMI 2000 HCG/ß-HCG
FDA 510(k) K192547 · Shenzhen New Industries Biomedical Engineering Co., Ltd.
510(k) numberK192547
Submission
- Device name
- MAGLUMI 2000 HCG/ß-HCG
- Applicant
- Shenzhen New Industries Biomedical Engineering Co., Ltd.
Shenzhen, CN - Received
- September 17, 2019
- Decision date
- January 17, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DHA – System, Test, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | Ortho Clinical Diagnostics | 05/08/2024SE |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)DHA · Traditional | Shenzhen Yhlo Biotech Co., Ltd. | 12/11/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | Abbott Laboratories | 06/05/2023SE |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…DHA · Traditional | Abbott Laboratories | 05/19/2023SE |
| K221990 | Access Total ßhCG (5th IS)DHA · Traditional | Beckman Coulter, Inc. | 12/27/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | Diazyme Laboratories, Inc. | 12/13/2021SE |
| K203227 | Elecsys HCG STATDHA · Traditional | Roche Diagnostics | 08/18/2021SE |
| K200210 | ADVIA Centaur® Total hCG assayDHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2021SE |
| K192790 | Atellica IM Total hCG (ThCG)DHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/30/2019SE |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i SystemDHA · Traditional | Abbott Laboratories | 10/23/2017SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerMRG · Traditional | 04/12/2024SE |
| K191499 | MAGLUMI 2000 25-OH Vitamin DMRG · Traditional | 08/01/2019SE |
| K182423 | Maglumi 2000 FT4CEC · Traditional | 10/04/2018SE |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW · Traditional | 07/14/2017SE |
Questions and answers
When was MAGLUMI 2000 HCG/ß-HCG cleared by the FDA?
MAGLUMI 2000 HCG/ß-HCG (K192547) received a 510(k) decision of Substantially Equivalent on January 17, 2020, 122 days after the submission was received.
What is the product code of K192547?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.