DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS— 510(k) K772098

Name: FDA 510(k) clearance K772098
Creator: U.S. Food and Drug Administration
Published: 1977-12-20

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K772098 for DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS, Substantially Equivalent on 1977-12-20. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 2.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code DON
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1977-11-07
Decision date: 1977-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DON

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K902861 — CIBA CORNING ACS DIGOXIN IMMUNOASSAY1990-09-10
K881679 — CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY1988-07-08
K840461 — MAGIC 125I DIGOXIN RADIOIMMUNOASSAY1984-03-23
K830533 — PHASE II DIGOXIN RADIOIMMUNOASSAY KIT1983-04-05
K822053 — ZETAPHASE-DIG1982-07-27

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