Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696
FDA 510(k) K020758 · Pharmacia Deutschland GmbH
510(k) numberK020758
Submission
- Device name
- Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696
- Applicant
- Pharmacia Deutschland GmbH
Freiburg, DE - Received
- March 7, 2002
- Decision date
- May 2, 2002
- 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 |
|---|---|---|
| K041043 | Varelisa PR3 Anca, Model Number 17748/17796MOB · Traditional | 07/02/2004SE |
| K040810 | Varelisa Histone Antibodies, Model 16496LJM · Traditional | 05/14/2004SE |
| K040811 | Varelisa Ssdna Antibodies, Model 14896LRM · Traditional | 05/13/2004SE |
| K040452 | Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096MSV · Traditional | 05/11/2004SE |
| K040451 | Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896MSV · Traditional | 05/11/2004SE |
| K040450 | Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996MSV · Traditional | 05/11/2004SE |
| K040449 | Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796MSV · Traditional | 05/11/2004SE |
| K020757 | Varelisa Cardiolipin Iga Antibodies, Models 15748 & 15796MID · Traditional | 05/02/2002SE |
| K020752 | Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596MID · Traditional | 05/02/2002SE |
Questions and answers
When was Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696 cleared by the FDA?
Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696 (K020758) received a 510(k) decision of Substantially Equivalent on May 2, 2002, 56 days after the submission was received.
What is the product code of K020758?
The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.