RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760— 510(k) K031308
Substantially EquivalentRhigene, Inc.
FDA 510(k) clearance K031308 for RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760, Substantially Equivalent on 2003-09-26. Applicant: Rhigene, Inc.. Device class: 2.
Clearance details
- Applicant
- Rhigene, Inc.
- Product code
- Code DBM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5090
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westminster, CO, US
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