QUANTA FLASH (TM) DGP SCREEN
FDA 510(k) clearance K111414 · decided 2011-10-20
Clearance details
- K-number
- K111414
- Device name
- QUANTA FLASH (TM) DGP SCREEN
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-20
- Decision date
- 2011-10-20
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- MST
- Device class
- 2
- Regulation number
- 866.5750
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.