RIA TEST KIT, CENTRIA DIGOXIN— 510(k) K790540

Name: FDA 510(k) clearance K790540
Creator: U.S. Food and Drug Administration
Published: 1979-04-23

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K790540 for RIA TEST KIT, CENTRIA DIGOXIN, Substantially Equivalent on 1979-04-23. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code DPB
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1979-03-20
Decision date: 1979-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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