Immulisa ANTI-BETA2 Glycoprotein I (B2GP1) Igm Elisa
FDA 510(k) K030702 · Immco Diagnostics, Inc.
510(k) numberK030702
Submission
- Device name
- Immulisa ANTI-BETA2 Glycoprotein I (B2GP1) Igm Elisa
- Applicant
- Immco Diagnostics, Inc.
Buffalo, NY, US - Received
- March 6, 2003
- Decision date
- September 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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| K243979 | Aptiva APS IgA ReagentMSV · Traditional | Inova Diagnostics, Inc. | 02/06/2026SE |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayMSV · Traditional | Phadia AB | 06/25/2018SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | Immco Diagnostics, Inc. | 06/19/2017SE |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar…MSV · Traditional | Inova Diagnostics, Inc. | 12/21/2015SE |
| K141274 | Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar ANTI-¿2GPI DOMAIN1; Controls.MSV · Traditional | Inova Diagnostics, Inc. | 02/13/2015SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | Phadia US, Inc. | 06/22/2012SE |
| K091556 | Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm ControlsMSV · Traditional | Instrumentation Laboratory CO | 05/21/2010SE |
| K092757 | Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCRMSV · Special | Thera-Test Laboratories, Inc. | 10/09/2009SE |
| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | Corgenix, Inc. | 04/04/2008SE |
| K062217 | Aeskulska BETA2-GLYCO-AMSV · Traditional | Aesku, Inc. | 12/13/2006SE |
More from Aesku, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172745 | ImmuGlo HEp-2 Elite IFADHN · Traditional | 06/05/2018SE |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISANYO · Traditional | 03/30/2018SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | 08/08/2017SE |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST · Traditional | 07/28/2017SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | 06/19/2017SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | 03/11/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | 09/23/2015SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | 03/31/2015SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | 10/25/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | 10/25/2012SE |
Questions and answers
When was Immulisa ANTI-BETA2 Glycoprotein I (B2GP1) Igm Elisa cleared by the FDA?
Immulisa ANTI-BETA2 Glycoprotein I (B2GP1) Igm Elisa (K030702) received a 510(k) decision of Substantially Equivalent on September 9, 2003, 187 days after the submission was received.
What is the product code of K030702?
The FDA product code is MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), a Class II (moderate risk) device regulated under 21 CFR 866.5660.