FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
INNOVANCE Antithrombin
K Number: K242952
·
Decision Mar 28, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
55
Applicant Total
4
Review Days
184
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Basic Information
- Device Name
- INNOVANCE Antithrombin
- K Number
- K242952
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7060
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostic Products GmbH
- Date Received
- September 25, 2024
- Decision Date
- March 28, 2025
- Product Code
- JBQ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JBQ | Antithrombin Iii Quantitation | FDA class 2 | Hematology |
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