FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HemosIL Chromogenic Factor IX
K Number: K230852
·
Decision Dec 13, 2023
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
3
Review Days
260
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Basic Information
- Device Name
- HemosIL Chromogenic Factor IX
- K Number
- K230852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory Company
- Date Received
- March 28, 2023
- Decision Date
- December 13, 2023
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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