Asserachrom PF4 Kit
FDA 510(k) K862774 · American Bioproducts Co.
510(k) numberK862774
Submission
- Device name
- Asserachrom PF4 Kit
- Applicant
- American Bioproducts Co.
Parsippany, NJ, US - Received
- July 22, 1986
- Decision date
- September 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsLCO · Traditional | Instrumentation Laboratory CO | 07/08/2016SE |
| 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 |
More from Diagnostica Stago, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983460 | Star Automated Multi-Parametric AnalyzerJPA · Traditional | 11/12/1998SE |
| K971519 | Asserachrom Tpa Test KitGGP · Traditional | 08/19/1997SE |
| K964728 | Sta-Liatest D-Di Test KitDAP · Traditional | 06/26/1997SE |
| K964716 | Sta Liatest Control [N]+[P] KitGGN · Traditional | 06/26/1997SE |
| K964718 | Sta D-Di Calibrator KitDAP · Traditional | 05/23/1997SE |
| K962675 | Sta - Liatest VWF Test KitGJT · Traditional | 10/25/1996SE |
| K962671 | Sta-Vwf Calibrator KitGJT · Traditional | 09/13/1996SE |
| K962674 | Sta - VWF Control [N]+[P] KitGGN · Traditional | 07/23/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | 07/10/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | 01/31/1996SE |
Questions and answers
When was Asserachrom PF4 Kit cleared by the FDA?
Asserachrom PF4 Kit (K862774) received a 510(k) decision of Substantially Equivalent on September 4, 1986, 44 days after the submission was received.
What is the product code of K862774?
The FDA product code is LCO – Platelet Factor 4 Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 864.7695.