VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT— 510(k) K791355

Name: FDA 510(k) clearance K791355
Creator: U.S. Food and Drug Administration
Published: 1979-08-10

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K791355 for VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1979-08-10. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code DPO
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1979-07-21
Decision date: 1979-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K905612 — VENTREX COATED TUBE IGE RADIOIMMUNOASSAY1991-02-21
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