Panels › Hematology › Product code LCO · Class 2
Platelet Factor 4 Radioimmunoassay
Regulation 864.7695
0510(k)s in 12 months (13 all time)
4recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in LCO
| Company | 510(k)s | Recalls |
|---|---|---|
| Hyphen Biomed | 1 | 5 |
| Genetic Testing Institute | 3 | 2 |
| Instrumentation Laboratory CO | 2 | 2 |
| Aniara Diagnostica LLC | 0 | 3 |
| Diagnostica Stago, Inc. | 1 | 1 |
| Immucor Gti Diagnostics, Inc. | 2 | 0 |
| Akers Laboratories, Inc. | 1 | 0 |
| American Bioproducts Co. | 1 | 0 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Instrumentation Laboratory (IL) Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2025 | K243374 | HemosIL CL HIT-IgG(PF4-H) Instrumentation Laboratory (IL) Co. | LCO |
| Sep 11, 2020 | K201570 | PF4 Enhanced assay Immucor Gti Diagnostics, Inc. | LCO |
| Jun 18, 2020 | K201311 | PF4 IgG assay Immucor Gti Diagnostics, Inc. | LCO |
| Sep 8, 2017 | K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls Instrumentation Laboratory CO | LCO |
| Jul 8, 2016 | K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls Instrumentation Laboratory CO | LCO |
| Dec 19, 2007 | K071781 | PF4 IGG Genetic Testing Institute | LCO |
| Sep 7, 2007 | K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A Hyphen Biomed | LCO |
| Jan 20, 2006 | K053559 | PF4 ENHANCED SOLID PHASE ELISA Genetic Testing Institute | LCO |
| May 28, 2004 | K040293 | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY Akers Laboratories, Inc. | LCO |
| Feb 12, 2001 | K003767 | ASSERACHROM HPIA TEST KIT Diagnostica Stago, Inc. | LCO |
| Mar 9, 1999 | K983379 | GTI-PF4 ELISA Genetic Testing Institute | LCO |
| Apr 21, 1989 | K890633 | ENZYGNOST PLATELET FACTOR 4 (PF4) KIT Behring Diagnostics, Inc. | LCO |
| Sep 4, 1986 | K862774 | ASSERACHROM PF4 KIT American Bioproducts Co. | LCO |
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