EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229— 510(k) K011920
Substantially EquivalentSyva Co., Dade Behring, Inc.
FDA 510(k) clearance K011920 for EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229, Substantially Equivalent on 2001-07-02. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Syva Co., Dade Behring, 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
- Special
- Location
- Cupertino, CA, 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 Syva Co., Dade Behring, Inc.
view all- K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
- K011605 — EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
- K011300 — EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
- K011306 — EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
- K011161 — MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
Data sourced from openFDA. This site is unofficial and independent of the FDA.