AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
FDA 510(k) clearance K070889 · decided 2008-04-14
Clearance details
- K-number
- K070889
- Device name
- AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
- Applicant
- Wallac OY
- Decision
- Substantially Equivalent
- Date received
- 2007-03-30
- Decision date
- 2008-04-14
- Days to decision
- 381 days
- Clearance type
- Traditional
- Product code
- CGZ
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Turku, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.