HemosIL CL HIT-IgG(PF4-H)
FDA 510(k) K243374 · Instrumentation Laboratory (IL) Co.
510(k) numberK243374
Submission
- Device name
- HemosIL CL HIT-IgG(PF4-H)
- Applicant
- Instrumentation Laboratory (IL) Co.
Bedford, MA, US - Received
- October 30, 2024
- Decision date
- January 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCO – Platelet Factor 4 Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7695
- Specialty
- Hematology
Other 510(k)s with product code LCO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201570 | PF4 Enhanced assayLCO · Special | Immucor Gti Diagnostics, Inc. | 09/11/2020SE |
| K201311 | PF4 IgG assayLCO · Special | Immucor Gti Diagnostics, Inc. | 06/18/2020SE |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsLCO · Traditional | Instrumentation Laboratory CO | 09/08/2017SE |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsLCO · Traditional | Instrumentation Laboratory CO | 07/08/2016SE |
| K071781 | PF4 IggLCO · Traditional | Genetic Testing Institute | 12/19/2007SE |
| K071255 | Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040ALCO · Traditional | Hyphen Biomed | 09/07/2007SE |
| K053559 | PF4 Enhanced Solid Phase ElisaLCO · Special | Genetic Testing Institute | 01/20/2006SE |
| K040293 | Healthtest Heparin/Platelet Factor 4 Antibody AssayLCO · Traditional | Akers Laboratories, Inc. | 05/28/2004SE |
| K003767 | Asserachrom Hpia Test KitLCO · Traditional | Diagnostica Stago, Inc. | 02/12/2001SE |
| K983379 | GTI-PF4 ElisaLCO · Traditional | Genetic Testing Institute | 03/09/1999SE |
More from Genetic Testing Institute
| 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 |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ · Special | 07/24/2025SE |
| 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 CL HIT-IgG(PF4-H) cleared by the FDA?
HemosIL CL HIT-IgG(PF4-H) (K243374) received a 510(k) decision of Substantially Equivalent on January 28, 2025, 90 days after the submission was received.
What is the product code of K243374?
The FDA product code is LCO – Platelet Factor 4 Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 864.7695.