NORDICLAB TESTOSTERONE RIA TEST— 510(k) K800921

Name: FDA 510(k) clearance K800921
Creator: U.S. Food and Drug Administration
Published: 1980-05-14

Substantially Equivalent

Nordiclab Intl.

FDA 510(k) clearance K800921 for NORDICLAB TESTOSTERONE RIA TEST, Substantially Equivalent on 1980-05-14. Applicant: Nordiclab Intl.. Device class: 1.

Clearance details

Applicant: Nordiclab Intl.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1980-04-21
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.