ENZYMUNE-TEST DIGOXIN— 510(k) K821000

Substantially Equivalent

Icl Scientific

FDA 510(k) clearance K821000 for ENZYMUNE-TEST DIGOXIN, Substantially Equivalent on 1982-04-26. Applicant: Icl Scientific. Device class: 2.

Clearance details

Applicant: Icl Scientific
Product code: Code DON
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1982-04-08
Decision date: 1982-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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

More clearances from Icl Scientific

K883942 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL1988-11-10
K843565 — KOVA TROL I,II, III HUMAN URINE-DRIED1984-10-05
K833761 — THERAPEUTIC DRUG CONTROL1984-01-13
K832823 — ENZYMUNE-TEST TSH1983-10-14
K831383 — EVENT-TEST SLIDE1983-06-22

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