FDA Product Code
FDA Product Code LCO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7695
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | 2025-01-28 | Traditional | PDF ↗ |
| K201570 | PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. | 2020-09-11 | Special | PDF ↗ |
| K201311 | PF4 IgG assay | Immucor Gti Diagnostics, Inc. | 2020-06-18 | Special | PDF ↗ |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017-09-08 | Traditional | PDF ↗ |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Instrumentation Laboratory CO | 2016-07-08 | Traditional | PDF ↗ |
| K071781 | PF4 IGG | Genetic Testing Institute | 2007-12-19 | Traditional | PDF ↗ |
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | Hyphen Biomed | 2007-09-07 | Traditional | PDF ↗ |
| K053559 | PF4 ENHANCED SOLID PHASE ELISA | Genetic Testing Institute | 2006-01-20 | Special | PDF ↗ |
| K040293 | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY | Akers Laboratories, Inc. | 2004-05-28 | Traditional | PDF ↗ |
| K003767 | ASSERACHROM HPIA TEST KIT | Diagnostica Stago, Inc. | 2001-02-12 | Traditional | PDF ↗ |
| K983379 | GTI-PF4 ELISA | Genetic Testing Institute | 1999-03-09 | Traditional | PDF ↗ |
| K890633 | ENZYGNOST PLATELET FACTOR 4 (PF4) KIT | Behring Diagnostics, Inc. | 1989-04-21 | Traditional | PDF ↗ |
| K862774 | ASSERACHROM PF4 KIT | American Bioproducts Co. | 1986-09-04 | Traditional | PDF ↗ |
Product code LCO · Class II · Hematology. Data: openFDA.