CEBTRIA DIGOXIN RIA— 510(k) K771255

Substantially Equivalent

Union Carbide Corp.

FDA 510(k) clearance K771255 for CEBTRIA DIGOXIN RIA, Substantially Equivalent on 1977-08-25. Applicant: Union Carbide Corp.. Device class: 2.

Clearance details

Applicant: Union Carbide Corp.
Product code: Code DON
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1977-07-12
Decision date: 1977-08-25
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 Union Carbide Corp.

K830337 — MARK III OXYGEN WALKER SYS-LOW PRESS1983-03-17
K820836 — MARK III OXYGEN WALKER SYSTEM1982-04-15
K820535 — LASER GAS MIXTURES1982-03-31
K812536 — LINDE MARK II1981-09-23
K810732 — LINDE MARK II OXYGEN RESERV. TYPE OR-41981-03-27

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