iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
FDA 510(k) K223690 · Shenzhen Yhlo Biotech Co., Ltd.
510(k) numberK223690
Submission
- Device name
- iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
- Applicant
- Shenzhen Yhlo Biotech Co., Ltd.
Shenzhen, CN - Received
- December 9, 2022
- Decision date
- December 11, 2023
- 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 |
| 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 |
| K192547 | MAGLUMI 2000 HCG/ß-HCGDHA · Traditional | Shenzhen New Industries Biomedical Engineering… | 01/17/2020SE |
| 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 |
Questions and answers
When was iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) cleared by the FDA?
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690) received a 510(k) decision of Substantially Equivalent on December 11, 2023, 367 days after the submission was received.
What is the product code of K223690?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.