RIA COAT DIGOXIN— 510(k) K833842

Substantially Equivalent

Immuno Assay Corp.

FDA 510(k) clearance K833842 for RIA COAT DIGOXIN, Substantially Equivalent on 1984-01-17. Applicant: Immuno Assay Corp.. Device class: 2.

Clearance details

Applicant: Immuno Assay Corp.
Product code: Code DPO
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1983-11-03
Decision date: 1984-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code DPO

K914833 — IMMULITE DIGOXIN1991-11-22
K905719 — ECLIPSE ICA DIGOXIN1991-01-17
K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT1987-02-02
K832163 — SOPHEIA DIGOXIN EIA KIT1983-08-12
K830962 — IMMUCHEM COVALENT-COAT RIA KIT1983-05-04

More clearances from Immuno Assay Corp.

K833745 — RIACOAT T-41984-01-04
K820074 — CORTISOL (RIA) KIT1982-01-28
K820089 — TSH (RIA) KIT1982-01-28
K811954 — COMBO-FER IRON DIAGNOSTIC1981-07-27
K811725 — TBG DIAGNOSTIC KIT1981-07-10

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