AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
FDA 510(k) clearance K081922 · decided 2009-04-16
Clearance details
- K-number
- K081922
- Device name
- AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- Applicant
- Wallac OY
- Decision
- Substantially Equivalent
- Date received
- 2008-07-07
- Decision date
- 2009-04-16
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- JLX
- Device class
- 1
- Regulation number
- 862.1395
- 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.