HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
FDA 510(k) K251968 · Instrumentation Laboratory (IL) Co.
510(k) numberK251968
Submission
- Device name
- HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
- Applicant
- Instrumentation Laboratory (IL) Co.
Bedford, MA, US - Received
- June 26, 2025
- Decision date
- July 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KQJ – System, Fibrinogen Determination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Specialty
- Hematology
Other 510(k)s with product code KQJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073367 | Hemosil Fibrinogen-CKQJ · Special | Instrumentation Laboratory CO | 12/27/2007SE |
| K050928 | Dade Thrombin ReagentKQJ · Traditional | Dade Behring, Inc. | 06/29/2005SE |
| K971858 | Sigma Diagnostics Fibrinogen Kit (886A/887A)KQJ · Traditional | Sigma Diagnostics, Inc. | 10/09/1997SE |
| K970189 | Fif TMKQJ · Traditional | Panbio, Inc. | 05/21/1997SE |
| K965113 | N-Assay Tia Fibrinogen Test KitKQJ · Traditional | Crestat Diagnostics, Inc. | 04/16/1997SE |
| K934326 | Multifibren UKQJ · Traditional | Behring Diagnostics, Inc. | 04/19/1994SE |
| K931721 | Il Test Fibrinogen-CKQJ · Traditional | Instrumentation Laboratory CO | 08/13/1993SE |
| K922416 | Fibrinogen Rid Test KitKQJ · Traditional | The Binding Site, Ltd. | 03/09/1993SE |
| K925988 | MultifibrenKQJ · Traditional | Behring Diagnostics, Inc. | 03/01/1993SE |
| K923593 | Hemochron/Factor Vi Fibrinogen Assay and Cont PlasKQJ · Traditional | International Technidyne Corp. | 09/22/1992SE |
More from International Technidyne Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V)GGW · Special | 03/20/2026SE |
| K253957 | HemosIL Silica Clotting TimeGFO · Special | 01/09/2026SE |
| K243374 | HemosIL CL HIT-IgG(PF4-H)LCO · Traditional | 01/28/2025SE |
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550…GKP · Special | 08/16/2024SE |
Questions and answers
When was HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL cleared by the FDA?
HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968) received a 510(k) decision of Substantially Equivalent on July 24, 2025, 28 days after the submission was received.
What is the product code of K251968?
The FDA product code is KQJ – System, Fibrinogen Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7340.