Cleared Traditional

INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)

K952505 · Nichols Institute · Chemistry
Jul 1995
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K952505 is an FDA 510(k) clearance for the INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA), 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 July 3, 1995, 33 days after receiving the submission on May 31, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K952505 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1995
Decision Date July 03, 1995
Days to Decision 33 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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