DUPONT DIGOXIN ASSAY REAGENTS— 510(k) K850458
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K850458 for DUPONT DIGOXIN ASSAY REAGENTS, Substantially Equivalent on 1985-03-05. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- 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
- Wilmington, DE, 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 E.I. Dupont DE Nemours & Co., Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.