EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
FDA 510(k) K181329 · Phadia AB
510(k) numberK181329
Submission
- Device name
- EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
- Applicant
- Phadia AB
Uppsala, SE - Received
- May 18, 2018
- Decision date
- June 25, 2018
- 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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Questions and answers
When was EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay cleared by the FDA?
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (K181329) received a 510(k) decision of Substantially Equivalent on June 25, 2018, 38 days after the submission was received.
What is the product code of K181329?
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.