Anti-Cardiolipin, Multiple Autoantibodies Immunological Test System
FDA 510(k) K003069 · Quest Intl., Inc.
510(k) numberK003069
Submission
- Device name
- Anti-Cardiolipin, Multiple Autoantibodies Immunological Test System
- Applicant
- Quest Intl., Inc.
North Miami, FL, US - Received
- October 2, 2000
- Decision date
- November 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MID – System, Test, Anticardiolipin Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MID
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID · Traditional | Inova Diagnostics, Inc. | 12/17/2024SE |
| K131821 | Elia(Tm) Cardiolipin Iga ImmunoassayMID · Traditional | Phadia US, Inc. | 12/23/2013SE |
| K130528 | Bioplex 2200 Apls IgmMID · Traditional | Bio-Rad Laboratories | 10/21/2013SE |
| K120817 | Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaMID · Traditional | Inova Diagnostics, Inc. | 02/26/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | Immco Diagnostics, Inc. | 10/25/2012SE |
| K103834 | Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsMID · Traditional | Bio-Rad Laboratories | 03/30/2012SE |
| K102425 | Zeus Elisa Cardiolipin Igg/Igm/Iga Test SystemMID · Traditional | Zeus Scientific, Inc. | 12/12/2011SE |
| K091845 | Cardiolipin Autoantibody Immunological Test SystemMID · Traditional | Phadia US, Inc. | 06/07/2010SE |
| K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsMID · Traditional | Instrumentation Laboratory CO | 03/11/2010SE |
| K060176 | El-Acl Screen; El-Acl Igm, Igg, IgaMID · Special | Theratest Laboratories, Inc. | 02/07/2006SE |
More from Theratest Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | 06/08/2009SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | 01/16/2004SE |
| K033780 | Modification to Seraquest Vca IgmLJN · Special | 01/15/2004SE |
| K023593 | Seraquest Anti-Thyroid Peroxidase (Tpo)JZO · Traditional | 02/06/2003SE |
| K023592 | Seraquest Anti-ThyroglobulinDDC · Traditional | 01/06/2003SE |
| K991975 | Seraquest Eb Na IggLSE · Traditional | 11/02/1999SE |
| K990410 | Seraquest Eb Vca IggLSE · Traditional | 10/28/1999SE |
| K990977 | Seraquest Eb Vac IgmLJN · Traditional | 10/06/1999SE |
| K982485 | Seraquest CMV IgmLFZ · Traditional | 01/13/1999SE |
| K982281 | Seraquest Rubella IgmLFX · Traditional | 10/16/1998SE |
Questions and answers
When was Anti-Cardiolipin, Multiple Autoantibodies Immunological Test System cleared by the FDA?
Anti-Cardiolipin, Multiple Autoantibodies Immunological Test System (K003069) received a 510(k) decision of Substantially Equivalent on November 27, 2000, 56 days after the submission was received.
What is the product code of K003069?
The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.