Diamedix IS-ANTI-B2 Glycoprotein I Screen
FDA 510(k) K013956 · Diamedix Corp.
510(k) numberK013956
Submission
- Device name
- Diamedix IS-ANTI-B2 Glycoprotein I Screen
- Applicant
- Diamedix Corp.
Miami, FL, US - Received
- November 30, 2001
- Decision date
- January 8, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | Corgenix, Inc. | 04/04/2008SE |
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| K013628 | Diamedix IS-ANTI-B2 Glycoprotein I Igg/Igm Test SystemMSV · Traditional | 12/21/2001SE |
| K012450 | Diamedix Is-Anti-Cardiolipin Iga Test SystemMID · Traditional | 10/26/2001SE |
| K012449 | Diamedix Is-Anti-Cardiolipin Igg/Igm Test SystemMID · Traditional | 10/26/2001SE |
| K012797 | Diamedix Is-Anti-Gliadin Iga Test SystemMST · Traditional | 09/28/2001SE |
| K012795 | Diamedix Is-Anti-Gliadin Igg Test SystemMST · Traditional | 09/28/2001SE |
| K012053 | Diamedix Is-Anti-Cardiolipin Screen Test SystemMID · Traditional | 08/20/2001SE |
| K002262 | Diamedix Is-Hsv 1&2 Igm Test SystemLGC · Traditional | 11/28/2000SE |
| K001875 | Diamedix Is-Rubella Igm Capture Test SystemLFX · Traditional | 08/21/2000SE |
Questions and answers
When was Diamedix IS-ANTI-B2 Glycoprotein I Screen cleared by the FDA?
Diamedix IS-ANTI-B2 Glycoprotein I Screen (K013956) received a 510(k) decision of Substantially Equivalent on January 8, 2002, 39 days after the submission was received.
What is the product code of K013956?
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.