QUANTA LITE SP100 ELISA
FDA 510(k) clearance K050662 · decided 2005-06-13
Clearance details
- K-number
- K050662
- Device name
- QUANTA LITE SP100 ELISA
- Applicant
- Inova Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-15
- Decision date
- 2005-06-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NUM
- Device class
- 2
- Regulation number
- 866.5090
- 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.