Diastat ANTI-B2 Glycoprotein 1 Igm, Model FBGP 100M
FDA 510(k) K031177 · Axis-Shield Diagnostics, Ltd.
510(k) numberK031177
Submission
- Device name
- Diastat ANTI-B2 Glycoprotein 1 Igm, Model FBGP 100M
- Applicant
- Axis-Shield Diagnostics, Ltd.
Dundee, GB - Received
- April 14, 2003
- Decision date
- June 19, 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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Questions and answers
When was Diastat ANTI-B2 Glycoprotein 1 Igm, Model FBGP 100M cleared by the FDA?
Diastat ANTI-B2 Glycoprotein 1 Igm, Model FBGP 100M (K031177) received a 510(k) decision of Substantially Equivalent on June 19, 2003, 66 days after the submission was received.
What is the product code of K031177?
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.