Cleared Traditional

DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)

K970701 · Diagnostic Systems Laboratories, Inc. · Chemistry
Apr 1997
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K970701 is an FDA 510(k) clearance for the DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900), a Radioimmunoassay, Human Growth Hormone (Class I — General Controls, product code CFL), submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on April 2, 1997, 35 days after receiving the submission on February 26, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K970701 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1997
Decision Date April 02, 1997
Days to Decision 35 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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