FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Atellica® IM High-Sensitivity Troponin I (TnIH)
K Number: K241165
·
Decision Jul 25, 2024
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
94
Applicant Total
152
Review Days
90
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Basic Information
- Device Name
- Atellica® IM High-Sensitivity Troponin I (TnIH)
- K Number
- K241165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- April 26, 2024
- Decision Date
- July 25, 2024
- Product Code
- MMI
- 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 |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | FDA class 2 | Clinical Chemistry |
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Other Clearances by Siemens Healthcare Diagnostics, Inc.
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|---|---|---|---|
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| K242981 | Atellica IM Thyroglobulin (Tg) | Jun 20, 2025 | Substantially Equivalent |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Dec 4, 2024 | Substantially Equivalent |
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| 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 |