RHIGENE HEP-ANA TEST SYSTEM— 510(k) K042680
Substantially EquivalentCorgenix, Inc.
FDA 510(k) clearance K042680 for RHIGENE HEP-ANA TEST SYSTEM, Substantially Equivalent on 2004-11-19. Applicant: Corgenix, Inc.. Device class: 2.
Clearance details
- Applicant
- Corgenix, Inc.
- Product code
- Code DHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
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