MID — System, Test, Anticardiolipin Immunological Class II
FDA product code MID covers "System, Test, Anticardiolipin Immunological", a Class II medical device regulated under 21 CFR 866.5660. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K022992 | corgenix | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | September 25, 2002 |
| K022990 | corgenix | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | September 25, 2002 |
| K021398 | louisville apl diagnostics | APL IGA ELISA KIT | August 27, 2002 |