MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
FDA 510(k) clearance K050960 · decided 2005-07-11
Clearance details
- K-number
- K050960
- Device name
- MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
- Applicant
- Wallac OY
- Decision
- Substantially Equivalent
- Date received
- 2005-04-18
- Decision date
- 2005-07-11
- Days to decision
- 84 days
- Clearance type
- Special
- 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.