DCA DIGOX-SYN RIA TEST— 510(k) K810477

Name: FDA 510(k) clearance K810477
Creator: U.S. Food and Drug Administration
Published: 1981-03-11

Substantially Equivalent

Diagnostic Corp. of America

FDA 510(k) clearance K810477 for DCA DIGOX-SYN RIA TEST, Substantially Equivalent on 1981-03-11. Applicant: Diagnostic Corp. of America. Device class: 2.

Clearance details

Applicant: Diagnostic Corp. of America
Product code: Code DOG
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1981-02-23
Decision date: 1981-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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