MID — System, Test, Anticardiolipin Immunological Class II
FDA Device Classification
Classification Details
- Product Code
- MID
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K223093 | inova diagnostics | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | December 17, 2024 |
| K131821 | phadia us | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | December 23, 2013 |
| K130528 | bio-rad laboratories | BIOPLEX 2200 APLS IGM | October 21, 2013 |
| K120817 | inova diagnostics | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA | February 26, 2013 |
| K113020 | immco diagnostics | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) | October 25, 2012 |
| K103834 | bio-rad laboratories | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS | March 30, 2012 |
| K102425 | zeus scientific | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | December 12, 2011 |
| K091845 | phadia us | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | June 7, 2010 |
| K092181 | instrumentation laboratory | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS | March 11, 2010 |
| K060176 | theratest laboratories | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | February 7, 2006 |
| K040463 | aesku | AESKULISA CARDIOLIPIN AGM | May 12, 2004 |
| K032868 | corgenix | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | October 14, 2003 |
| K032240 | binding site | BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT | September 29, 2003 |
| K030741 | hycor biomedical | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA | May 1, 2003 |
| K024195 | corgenix | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | January 3, 2003 |
| K024196 | corgenix | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | January 3, 2003 |
| K023433 | pharmacia diagnostics gmbh and co. kg | VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 | November 13, 2002 |
| K022990 | corgenix | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | September 25, 2002 |
| K022992 | corgenix | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | September 25, 2002 |
| K021398 | louisville apl diagnostics | APL IGA ELISA KIT | August 27, 2002 |