Product code LCO
- Device name
- Platelet Factor 4 Radioimmunoassay
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7695
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | 2025-01-28 |
| K201570 | PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. | 2020-09-11 |
| K201311 | PF4 IgG assay | Immucor Gti Diagnostics, Inc. | 2020-06-18 |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017-09-08 |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Instrumentation Laboratory CO | 2016-07-08 |
| K071781 | PF4 IGG | Genetic Testing Institute | 2007-12-19 |
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | Hyphen Biomed | 2007-09-07 |
| K053559 | PF4 ENHANCED SOLID PHASE ELISA | Genetic Testing Institute | 2006-01-20 |
| K040293 | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | Akers Laboratories, Inc. | 2004-05-28 |
| K003767 | ASSERACHROM HPIA TEST KIT | Diagnostica Stago, Inc. | 2001-02-12 |
| K983379 | GTI-PF4 ELISA | Genetic Testing Institute | 1999-03-09 |
| K890633 | ENZYGNOST PLATELET FACTOR 4 (PF4) KIT | Behring Diagnostics, Inc. | 1989-04-21 |
| K862774 | ASSERACHROM PF4 KIT | American Bioproducts Co. | 1986-09-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195226001204 | HemosIL CL HIT-IgG (PF4-H) | INSTRUMENTATION LABORATORY COMPANY | 2025-10-30 |
| 08426951126545 | HemosIL AcuStar HIT-IgG (PF4-H) | INSTRUMENTATION LABORATORY COMPANY | 2018-07-12 |
| 00708872000042 | PIFA PLUSS® PF4 Rapid Assay | AKERS BIOSCIENCES, INC. | 2018-06-04 |
| 00708872615124 | PIFA PLUSS® PF4 Rapid Assay | AKERS BIOSCIENCES, INC. | 2018-06-04 |
| 00708872615123 | PIFA® Heparin/PF4 Rapid Assay | AKERS BIOSCIENCES, INC. | 2016-09-24 |
| 08426950975380 | HemosIL HIT-Ab(PF4-H) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 03607450009514 | Asserachrom® PF4 | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450006155 | Asserachrom® HPIA | DIAGNOSTICA STAGO | 2016-09-15 |
| 03663537046810 | ZYMUTEST HIA MonoStrip IgGAM | HYPHEN BIOMED | 2016-08-25 |
| 03663537018763 | ZYMUTEST HIA IgG | HYPHEN BIOMED | 2016-08-25 |
| 03663537018770 | ZYMUTEST HIA IgGAM | HYPHEN BIOMED | 2016-08-25 |
| 03663537046803 | ZYMUTEST HIA MonoStrip IgG | HYPHEN BIOMED | 2016-08-25 |
| 10888234500032 | PF4 Enhanced® | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500049 | PF4 IgG | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500056 | PF4 IgG | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500353 | Specimen Diluent | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500384 | Anti-Human IgG Conjugate | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500391 | Anti-Human IgG/A/M Conjugate | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500414 | Negative Serum Control | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500421 | PF4 Concentrated Wash (10x) | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500438 | Positive Serum Control | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-08 |
| 10888234500025 | PF4 Enhanced® | IMMUCOR GTI DIAGNOSTICS, INC. | 2016-07-01 |