ENZYME-TEST DIGOXIN— 510(k) K823199
Substantially EquivalentIcl Scientific
FDA 510(k) clearance K823199 for ENZYME-TEST DIGOXIN, Substantially Equivalent on 1982-11-29. Applicant: Icl Scientific. Device class: 2.
Clearance details
- Applicant
- Icl Scientific
- 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
- Mchenry, IL, US
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 Icl Scientific
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