INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY— 510(k) K955390

Name: FDA 510(k) clearance K955390
Creator: U.S. Food and Drug Administration
Published: 1995-12-29

Substantially Equivalent

Corning Nichols Diagnostics

FDA 510(k) clearance K955390 for INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY, Substantially Equivalent on 1995-12-29. Applicant: Corning Nichols Diagnostics. Device class: 1.

Clearance details

Applicant: Corning Nichols Diagnostics
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1995-11-24
Decision date: 1995-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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