RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
FDA 510(k) clearance K031308 · decided 2003-09-26
Clearance details
- K-number
- K031308
- Device name
- RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760
- Applicant
- Rhigene, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-24
- Decision date
- 2003-09-26
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- DBM
- Device class
- 2
- Regulation number
- 866.5090
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Westminster, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.