QUANTIA LA(A)
FDA 510(k) clearance K050487 · decided 2005-04-26
Clearance details
- K-number
- K050487
- Device name
- QUANTIA LA(A)
- Applicant
- Biokit, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-25
- Decision date
- 2005-04-26
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- DFC
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Barcelona, ES
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.