(125I) TESTOSTERONE KIT— 510(k) K791999

Name: FDA 510(k) clearance K791999
Creator: U.S. Food and Drug Administration
Published: 1979-10-30

Substantially Equivalent

Radioassay Systems Laboratories, Inc.

FDA 510(k) clearance K791999 for (125I) TESTOSTERONE KIT, Substantially Equivalent on 1979-10-30. Applicant: Radioassay Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Radioassay Systems Laboratories, Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1979-10-05
Decision date: 1979-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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