LCO — Platelet Factor 4 Radioimmunoassay Class II
FDA product code LCO covers "Platelet Factor 4 Radioimmunoassay", a Class II medical device regulated under 21 CFR 864.7695. Submissions are reviewed by the Hematology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LCO
- Device Class
- Class II
- Regulation Number
- 864.7695
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243374 | instrumentation laboratory (il) | HemosIL CL HIT-IgG(PF4-H) | January 28, 2025 |
| K201570 | immucor gti diagnostics | PF4 Enhanced assay | September 11, 2020 |
| K201311 | immucor gti diagnostics | PF4 IgG assay | June 18, 2020 |
| K170854 | instrumentation laboratory | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | September 8, 2017 |
| K153137 | instrumentation laboratory | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | July 8, 2016 |
| K071781 | genetic testing institute | PF4 IGG | December 19, 2007 |
| K071255 | hyphen biomed | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | September 7, 2007 |
| K053559 | genetic testing institute | PF4 ENHANCED SOLID PHASE ELISA | January 20, 2006 |
| K040293 | akers laboratories | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | May 28, 2004 |
| K003767 | diagnostica stago | ASSERACHROM HPIA TEST KIT | February 12, 2001 |
| K983379 | genetic testing institute | GTI-PF4 ELISA | March 9, 1999 |
| K890633 | behring diagnostics | ENZYGNOST PLATELET FACTOR 4 (PF4) KIT | April 21, 1989 |
| K862774 | american bioproducts | ASSERACHROM PF4 KIT | September 4, 1986 |