ACTIVE RENIN IMMUNORADIOMETRIC ASSAY— 510(k) K925998

Name: FDA 510(k) clearance K925998
Creator: U.S. Food and Drug Administration
Published: 1993-01-06

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K925998 for ACTIVE RENIN IMMUNORADIOMETRIC ASSAY, Substantially Equivalent on 1993-01-06. Applicant: Nichols Institute Diagnostics. Device class: 2.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code CIB
Device class: Class 2
Regulation: 21 CFR 862.1085
Advisory panel: Clinical Chemistry
Date received: 1992-11-27
Decision date: 1993-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

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