FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
K Number: K251968
·
Decision Jul 24, 2025
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
27
Applicant Total
5
Review Days
28
Basic Information
- Device Name
- HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
- K Number
- K251968
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7340
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory (IL) Co.
- Date Received
- June 26, 2025
- Decision Date
- July 24, 2025
- Product Code
- KQJ
- 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 |
|---|---|---|---|
| KQJ | System, Fibrinogen Determination | FDA class 2 | Hematology |
Similar 510(k) Clearances
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Other Clearances by Instrumentation Laboratory (IL) Co.
| K Number | Device Name | ||
|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Mar 20, 2026 | Substantially Equivalent |
| K253957 | HemosIL Silica Clotting Time | Jan 9, 2026 | Substantially Equivalent |
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Jan 28, 2025 | Substantially Equivalent |
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | Aug 16, 2024 | Substantially Equivalent |