FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
K Number: DEN190056
·
Decision Aug 20, 2021
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
152
Review Days
603
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Basic Information
- Device Name
- ADVIA Centaur Enhanced Liver Fibrosis (ELF)
- K Number
- DEN190056
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 862.1622
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- December 26, 2019
- Decision Date
- August 20, 2021
- Product Code
- QQB
- 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 |
|---|---|---|---|
| QQB | Prognostic Test For Assessment Of Liver Related Disease Progression | FDA class 2 | Clinical Chemistry |
Other Clearances by Siemens Healthcare Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Feb 27, 2026 | Substantially Equivalent |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Feb 6, 2026 | Substantially Equivalent |
| K251630 | Atellica IM Total PSA II (tPSAII) | Jan 5, 2026 | Substantially Equivalent |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Dec 4, 2025 | Substantially Equivalent |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Oct 17, 2025 | Substantially Equivalent |
| K242981 | Atellica IM Thyroglobulin (Tg) | Jun 20, 2025 | Substantially Equivalent |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Dec 4, 2024 | Substantially Equivalent |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Jul 26, 2024 | Substantially Equivalent |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Jul 25, 2024 | Substantially Equivalent |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Apr 4, 2024 | Substantially Equivalent |