QUANTA PLEX SLE PROFILE 8
FDA 510(k) clearance K040160 · decided 2004-03-08
Clearance details
- K-number
- K040160
- Device name
- QUANTA PLEX SLE PROFILE 8
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-23
- Decision date
- 2004-03-08
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- 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.