HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
FDA 510(k) K153137 · Instrumentation Laboratory CO
510(k) numberK153137
Submission
- Device name
- HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- October 30, 2015
- Decision date
- July 8, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCO – Platelet Factor 4 Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7695
- Specialty
- Hematology
Other 510(k)s with product code LCO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243374 | HemosIL CL HIT-IgG(PF4-H)LCO · Traditional | Instrumentation Laboratory (IL) Co. | 01/28/2025SE |
| K201570 | PF4 Enhanced assayLCO · Special | Immucor Gti Diagnostics, Inc. | 09/11/2020SE |
| K201311 | PF4 IgG assayLCO · Special | Immucor Gti Diagnostics, Inc. | 06/18/2020SE |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsLCO · Traditional | Instrumentation Laboratory CO | 09/08/2017SE |
| K071781 | PF4 IggLCO · Traditional | Genetic Testing Institute | 12/19/2007SE |
| K071255 | Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040ALCO · Traditional | Hyphen Biomed | 09/07/2007SE |
| K053559 | PF4 Enhanced Solid Phase ElisaLCO · Special | Genetic Testing Institute | 01/20/2006SE |
| K040293 | Healthtest Heparin/Platelet Factor 4 Antibody AssayLCO · Traditional | Akers Laboratories, Inc. | 05/28/2004SE |
| K003767 | Asserachrom Hpia Test KitLCO · Traditional | Diagnostica Stago, Inc. | 02/12/2001SE |
| K983379 | GTI-PF4 ElisaLCO · Traditional | Genetic Testing Institute | 03/09/1999SE |
More from Genetic Testing Institute
| 510(k) | Device | Decision |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls cleared by the FDA?
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls (K153137) received a 510(k) decision of Substantially Equivalent on July 8, 2016, 252 days after the submission was received.
What is the product code of K153137?
The FDA product code is LCO – Platelet Factor 4 Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 864.7695.