RADIOASSAY FOR TOTAL SERUM THYROXINE— 510(k) K780644

Name: FDA 510(k) clearance K780644
Creator: U.S. Food and Drug Administration
Published: 1978-04-28

Substantially Equivalent

Nuclear Diagnostics, Inc.

FDA 510(k) clearance K780644 for RADIOASSAY FOR TOTAL SERUM THYROXINE, Substantially Equivalent on 1978-04-28. Applicant: Nuclear Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Nuclear Diagnostics, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1978-04-17
Decision date: 1978-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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