DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
FDA 510(k) clearance K031177 · decided 2003-06-19
Clearance details
- K-number
- K031177
- Device name
- DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-14
- Decision date
- 2003-06-19
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- MSV
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.