SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES— 510(k) K884528
Substantially EquivalentHeraeus Kulzer, Inc.
FDA 510(k) clearance K884528 for SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES, Substantially Equivalent on 1989-03-08. Applicant: Heraeus Kulzer, Inc.. Device class: 2.
Clearance details
- Applicant
- Heraeus Kulzer, 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
- Elkhart, IN, 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 Heraeus Kulzer, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.