AUTO DELFIA
FDA 510(k) clearance K935047 · decided 1994-05-23
Clearance details
- K-number
- K935047
- Device name
- AUTO DELFIA
- Applicant
- Wallac OY
- Decision
- Substantially Equivalent
- Date received
- 1993-10-21
- Decision date
- 1994-05-23
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- KHO
- Device class
- 1
- Regulation number
- 862.2560
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Finland, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.