Cleared Traditional

IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3

K946247 · Nichols Institute · Chemistry
Jun 1995
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K946247 is an FDA 510(k) clearance for the IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3, a Radioimmunoassay, Human Growth Hormone (Class I — General Controls, product code CFL), submitted by Nichols Institute (San Juan Capistrano, US). The FDA issued a Cleared decision on June 23, 1995, 183 days after receiving the submission on December 22, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K946247 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1994
Decision Date June 23, 1995
Days to Decision 183 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFL — Radioimmunoassay, Human Growth Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1370

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