Elia B2-GLYCOPROTEIN I Iga Immunoassay
FDA 510(k) K112414 · Phadia US, Inc.
510(k) numberK112414
Submission
- Device name
- Elia B2-GLYCOPROTEIN I Iga Immunoassay
- Applicant
- Phadia US, Inc.
Portage, MI, US - Received
- August 22, 2011
- Decision date
- June 22, 2012
- 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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| K062217 | Aeskulska BETA2-GLYCO-AMSV · Traditional | Aesku, Inc. | 12/13/2006SE |
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Questions and answers
When was Elia B2-GLYCOPROTEIN I Iga Immunoassay cleared by the FDA?
Elia B2-GLYCOPROTEIN I Iga Immunoassay (K112414) received a 510(k) decision of Substantially Equivalent on June 22, 2012, 305 days after the submission was received.
What is the product code of K112414?
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.