TIPSEP-CORTISOL RIA DIAGNOSTIC KIT— 510(k) K872177

Name: FDA 510(k) clearance K872177
Creator: U.S. Food and Drug Administration
Published: 1987-06-17

Substantially Equivalent

Nuclear Diagnostics, Inc.

FDA 510(k) clearance K872177 for TIPSEP-CORTISOL RIA DIAGNOSTIC KIT, Substantially Equivalent on 1987-06-17. Applicant: Nuclear Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Nuclear Diagnostics, Inc.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1987-06-08
Decision date: 1987-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

Download summary PDF View on FDA.gov ↗

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