FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Atellica® CH Creatinine_3 (Crea3)
K Number: K242685
·
Decision Dec 4, 2024
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
152
Review Days
89
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Basic Information
- Device Name
- Atellica® CH Creatinine_3 (Crea3)
- K Number
- K242685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- September 6, 2024
- Decision Date
- December 4, 2024
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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