QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA— 510(k) K772422

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K772422 for QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA, Substantially Equivalent on 1978-02-13. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code DON
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1977-12-28
Decision date: 1978-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DON

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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Data sourced from openFDA. This site is unofficial and independent of the FDA.