Cleared Traditional

DSL 9100 IGF-II IRMA

K962758 · Diagnostic Systems Laboratories, Inc. · Chemistry
Aug 1996
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K962758 is an FDA 510(k) clearance for the DSL 9100 IGF-II IRMA, 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 August 30, 1996, 45 days after receiving the submission on July 16, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K962758 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1996
Decision Date August 30, 1996
Days to Decision 45 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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