FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Atellica IM Total hCG (ThCG)
K Number: K172322
·
Decision Mar 29, 2018
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
152
Review Days
240
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Basic Information
- Device Name
- Atellica IM Total hCG (ThCG)
- K Number
- K172322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- August 1, 2017
- Decision Date
- March 29, 2018
- Product Code
- JHI
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| K242685 | Atellica® CH Creatinine_3 (Crea3) | Dec 4, 2024 | Substantially Equivalent |
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| 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 |