DIGOXIN RIA ASSAY— 510(k) K810296

Substantially Equivalent

Ria Diagnostics

FDA 510(k) clearance K810296 for DIGOXIN RIA ASSAY, Substantially Equivalent on 1981-02-19. Applicant: Ria Diagnostics. Device class: 2.

Clearance details

Applicant: Ria Diagnostics
Product code: Code DON
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1981-02-04
Decision date: 1981-02-19
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 Ria Diagnostics

K855033 — T-3 UPTAKE/RIASSAY1986-01-24
K854798 — T-4 RIASSAY1986-01-15
K852537 — T-3 RIASSAY1985-08-12
K801691 — TSH RIASSAY1980-08-27
K792062 — THEOPHYLLINE RIASSAY1980-02-25

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