ENDAB DIGOXIN KIT— 510(k) K812054
Substantially EquivalentImmunotech Corp.
FDA 510(k) clearance K812054 for ENDAB DIGOXIN KIT, Substantially Equivalent on 1981-08-12. Applicant: Immunotech Corp.. Device class: 2.
Clearance details
- Applicant
- Immunotech Corp.
- 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
view all- K193397 — ADVIA Centaur® Digoxin assay
- K153301 — Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
- K102346 — RANDOX DIGOXIN ASSAY
- K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
- K082953 — ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
More clearances from Immunotech Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.