(125 I) DIGITOXIN RIA KIT— 510(k) K780766

Name: FDA 510(k) clearance K780766
Creator: U.S. Food and Drug Administration
Published: 1978-07-27

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K780766 for (125 I) DIGITOXIN RIA KIT, Substantially Equivalent on 1978-07-27. Applicant: Diagnostic Products Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code LCW
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1978-05-05
Decision date: 1978-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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