ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)— 510(k) K932732
Substantially EquivalentDupont Medical Products
FDA 510(k) clearance K932732 for ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN), Substantially Equivalent on 1993-11-15. Applicant: Dupont Medical Products. Device class: 2.
Clearance details
- Applicant
- Dupont Medical Products
- 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 Dupont Medical Products
view allData sourced from openFDA. This site is unofficial and independent of the FDA.