Cleared Traditional

HUMAN GROWTH HORMONE IMMUNOASSAY KIT

K961678 · Nichols Institute Diagnostics · Chemistry
Jul 1996
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K961678 is an FDA 510(k) clearance for the HUMAN GROWTH HORMONE IMMUNOASSAY KIT, a Radioimmunoassay, Human Growth Hormone (Class I — General Controls, product code CFL), submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on July 8, 1996, 68 days after receiving the submission on May 1, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K961678 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1996
Decision Date July 08, 1996
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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