ADVIA Centaur® Digoxin assay— 510(k) K193397
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K193397 for ADVIA Centaur® Digoxin assay, Substantially Equivalent on 2021-07-16. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, 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
- Tarrytown, NY, US
Recent devices under product code KXT
view all- 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
- K061249 — AXSYM DIGOXIN III
More clearances from Siemens Healthcare Diagnostics, Inc.
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