REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001— 510(k) K031208
Substantially EquivalentCorgenix, Inc.
FDA 510(k) clearance K031208 for REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001, Substantially Equivalent on 2003-07-07. Applicant: Corgenix, Inc.. Device class: 2.
Clearance details
- Applicant
- Corgenix, Inc.
- Product code
- Code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Westminster, CO, US
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