Cardiolipin Igg,M,A Eia Test System
FDA 510(k) K951363 · Immunoprobe, Inc.
510(k) numberK951363
Submission
- Device name
- Cardiolipin Igg,M,A Eia Test System
- Applicant
- Immunoprobe, Inc.
Washington, D.C., DC, US - Received
- March 24, 1995
- Decision date
- October 13, 1995
- 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 |
|---|---|---|
| K972406 | Adenovirus Antigen Detection Elisa Test SystemGOD · Traditional | 12/22/1997SE |
| K971393 | Mycoplasma Igg Elisa Test SystemLJZ · Traditional | 07/14/1997SE |
| K961765 | Mpo Elisa Test SystemMOB · Traditional | 08/19/1996SE |
| K961764 | PR-3 Elisa Test SystemMOB · Traditional | 08/19/1996SE |
| K951549 | Ebna Igg Eia Test SystemLLM · Traditional | 04/29/1996SE |
| K952523 | Cardiolipin Igg Eia Test KitMID · Traditional | 02/09/1996SE |
| K952522 | Cardiolipin Iga Eia Test SystemMID · Traditional | 02/09/1996SE |
| K952521 | Cardiolipin Igm Eia Test SystemMID · Traditional | 02/09/1996SE |
| K951364 | Microsomal Eia Test KitJNL · Traditional | 11/20/1995SE |
| K951362 | Thyroglobulin Eia Test KitJNL · Traditional | 11/20/1995SE |
Questions and answers
When was Cardiolipin Igg,M,A Eia Test System cleared by the FDA?
Cardiolipin Igg,M,A Eia Test System (K951363) received a 510(k) decision of Substantially Equivalent on October 13, 1995, 203 days after the submission was received.
What is the product code of K951363?
The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.