DIGOXIN (RIA) KIT— 510(k) K811212

Substantially Equivalent

Immuno Assay Corp.

FDA 510(k) clearance K811212 for DIGOXIN (RIA) KIT, Substantially Equivalent on 1981-05-21. Applicant: Immuno Assay Corp.. Device class: 2.

Clearance details

Applicant: Immuno Assay Corp.
Product code: Code DNL
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1981-05-04
Decision date: 1981-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DNL

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K852291 — TIPSEP DIGOXIN RIA1985-06-25
K810966 — DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT1981-04-21
K802841 — DIGOXIN RADIOIMMUNOASSAY KIT1980-12-18
K781834 — TEST SET, 125 I-DIGOXIN1979-01-03

More clearances from Immuno Assay Corp.

K833842 — RIA COAT DIGOXIN1984-01-17
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

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