FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys HCG STAT
K Number: K203227
·
Decision Aug 18, 2021
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
183
Review Days
289
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Elecsys HCG STAT
- K Number
- K203227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- November 2, 2020
- Decision Date
- August 18, 2021
- Product Code
- DHA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHA), ordered by most recent decision date.
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Total ßhCG (5th IS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Roche Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring system | Jun 12, 2026 | Substantially Equivalent |
| K252280 | Elecsys Anti-SARS-CoV-2 S | Apr 13, 2026 | Substantially Equivalent |
| K260048 | Elecsys Anti-HAV IgM | Apr 7, 2026 | Substantially Equivalent |
| K260049 | Elecsys Anti-HBc IgM | Apr 7, 2026 | Substantially Equivalent |
| K260046 | Elecsys Anti-HBc II | Apr 7, 2026 | Substantially Equivalent |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | Apr 2, 2026 | Substantially Equivalent |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Feb 12, 2026 | Substantially Equivalent |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Feb 12, 2026 | Substantially Equivalent |
| K253839 | Elecsys Anti-SARS-CoV-2 | Dec 17, 2025 | Substantially Equivalent |
| K253188 | CoaguChek XS Plus System | Oct 24, 2025 | Substantially Equivalent |