FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Atellica® IM TSH3-Ultra II (TSH3ULII)
K Number: K251543
·
Decision Feb 6, 2026
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
152
Review Days
262
Basic Information
- Device Name
- Atellica® IM TSH3-Ultra II (TSH3ULII)
- K Number
- K251543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- May 20, 2025
- Decision Date
- February 6, 2026
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Siemens Healthcare Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Feb 27, 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 |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Jan 18, 2024 | Substantially Equivalent |