Platelet Factor 4 Radioimmunoassay
Platelet factor 4 radioimmunoassay is a laboratory test system that uses radiolabeled antibodies to measure platelet factor 4, a protein released from platelet alpha-granules, in patient blood samples to assess platelet activation and disorders such as heparin-induced thrombocytopenia. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LCO, regulated under 21 CFR 864.7695, in the Hematology specialty. Third-party review is available.
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Basic Information
- Product Code
- LCO
- Device Class
- FDA class 2
- Regulation Number
- 864.7695
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Jan 28, 2025 | Substantially Equivalent | Instrumentation Laboratory (IL) Co. |
| K201570 | PF4 Enhanced assay | Sep 11, 2020 | Substantially Equivalent | Immucor Gti Diagnostics, Inc. |
| K201311 | PF4 IgG assay | Jun 18, 2020 | Substantially Equivalent | Immucor Gti Diagnostics, Inc. |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Sep 08, 2017 | Substantially Equivalent | Instrumentation Laboratory CO |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Jul 08, 2016 | Substantially Equivalent | Instrumentation Laboratory CO |
| K071781 | PF4 IGG | Dec 19, 2007 | Substantially Equivalent | Genetic Testing Institute |
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | Sep 07, 2007 | Substantially Equivalent | Hyphen Biomed |
| K053559 | PF4 ENHANCED SOLID PHASE ELISA | Jan 20, 2006 | Substantially Equivalent | Genetic Testing Institute |
| K040293 | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | May 28, 2004 | Substantially Equivalent | Akers Laboratories, Inc. |
| K003767 | ASSERACHROM HPIA TEST KIT | Feb 12, 2001 | Substantially Equivalent | Diagnostica Stago, Inc. |
| K983379 | GTI-PF4 ELISA | Mar 09, 1999 | Substantially Equivalent | Genetic Testing Institute |
| K890633 | ENZYGNOST PLATELET FACTOR 4 (PF4) KIT | Apr 21, 1989 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K862774 | ASSERACHROM PF4 KIT | Sep 04, 1986 | Substantially Equivalent | American Bioproducts Co. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.