DIGOXIN DG-II FPIA REAGENT SET— 510(k) K972794
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K972794 for DIGOXIN DG-II FPIA REAGENT SET, Substantially Equivalent on 1997-07-31. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma 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
- St. Louis, MO, 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 Sigma Diagnostics, Inc.
view all- K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
- K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
- K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
- K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
- K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
Data sourced from openFDA. This site is unofficial and independent of the FDA.