DHA — System, Test, Human Chorionic Gonadotropin Class II
FDA product code DHA covers "System, Test, Human Chorionic Gonadotropin", a Class II medical device regulated under 21 CFR 862.1155. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DHA
- Device Class
- Class II
- Regulation Number
- 862.1155
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233581 | ortho clinical diagnostics | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | May 8, 2024 |
| K223690 | shenzhen yhlo biotech co | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | December 11, 2023 |
| K230937 | abbott laboratories | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | June 5, 2023 |
| K230790 | abbott laboratories | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT | May 19, 2023 |
| K221990 | beckman coulter | Access Total ßhCG (5th IS) | December 27, 2022 |
| K212221 | diazyme laboratories | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu | December 13, 2021 |
| K203227 | roche diagnostics | Elecsys HCG STAT | August 18, 2021 |
| K200210 | siemens healthcare diagnostics | ADVIA Centaur® Total hCG assay | July 13, 2021 |
| K192547 | shenzhen new industries biomedical engineering co | MAGLUMI 2000 HCG/ß-HCG | January 17, 2020 |
| K192790 | siemens healthcare diagnostics | Atellica IM Total hCG (ThCG) | October 30, 2019 |
| K170317 | abbott laboratories | Alinity i Total ß-hCG Reagent Kit, Alinity i System | October 23, 2017 |
| K163418 | diazyme laboratories | Diazyme DZ-Lite Total beta-hCG Test System | August 18, 2017 |
| K133002 | abbott point of care | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hC | April 16, 2015 |
| K130020 | beckman coulter | ACCESS TOTAL BHCG (5TH IS) | October 1, 2013 |
| K131037 | diasorin | LIAISON XL HCG | September 6, 2013 |
| K072500 | guangzhou wondfo biotech co | ONE STEP HCG URINE/SERUM TEST | April 21, 2009 |
| K080094 | olympus life science research europa gmbh (europa) | OLYMPUS TOTAL BHCG TEST SYSTEN | September 3, 2008 |
| K063720 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE | April 9, 2007 |
| K063754 | dade behring | DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# | February 23, 2007 |
| K060548 | dade behring | STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AN | April 6, 2006 |