DELFIA DIGOXIN KIT— 510(k) K924594
Substantially EquivalentWallac OY
FDA 510(k) clearance K924594 for DELFIA DIGOXIN KIT, Substantially Equivalent on 1992-12-17. Applicant: Wallac OY. Device class: 2.
Clearance details
- Applicant
- Wallac OY
- Product code
- Code KXT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Finland, FI
Recent devices under product code KXT
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- K082953 — ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
More clearances from Wallac OY
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- K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.