IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3— 510(k) K946247

Name: FDA 510(k) clearance K946247
Creator: U.S. Food and Drug Administration
Published: 1995-06-23

Substantially Equivalent

Nichols Institute

FDA 510(k) clearance K946247 for IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3, Substantially Equivalent on 1995-06-23. Applicant: Nichols Institute. Device class: 1.

Clearance details

Applicant: Nichols Institute
Product code: Code CFL
Device class: Class 1
Regulation: 21 CFR 862.1370
Advisory panel: Clinical Chemistry
Date received: 1994-12-22
Decision date: 1995-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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