DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M— 510(k) K031177
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K031177 for DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M, Substantially Equivalent on 2003-06-19. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 2.
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Product code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
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