QUANTA PLEX CELIAC IGG PROFILE
FDA 510(k) clearance K072632 · decided 2008-02-11
Clearance details
- K-number
- K072632
- Device name
- QUANTA PLEX CELIAC IGG PROFILE
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-18
- Decision date
- 2008-02-11
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- MVM
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.