iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
FDA 510(k) clearance K223690 · decided 2023-12-11
Clearance details
- K-number
- K223690
- Device name
- iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
- Applicant
- Shenzhen Yhlo Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-09
- Decision date
- 2023-12-11
- Days to decision
- 367 days
- Clearance type
- Traditional
- Product code
- DHA
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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| ADVIA Centaur® Total hCG assay (K200210) | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 |
| MAGLUMI 2000 HCG/ß-HCG (K192547) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 |
| Atellica IM Total hCG (ThCG) (K192790) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 |
| Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317) | Abbott Laboratories | 2017-10-23 |
| Diazyme DZ-Lite Total beta-hCG Test System (K163418) | Diazyme Laboratories | 2017-08-18 |
| i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002) | Abbott Point of Care, Inc. | 2015-04-16 |
Recalls involving this device
No recalls on record reference this clearance.