Cleared Traditional

DSL ACTIVE NON-EXTRACTION IGF-I ELISA

K971353 · Diagnostic Systems Laboratories, Inc. · Chemistry
May 1997
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K971353 is an FDA 510(k) clearance for the DSL ACTIVE NON-EXTRACTION IGF-I ELISA, 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 May 12, 1997, 31 days after receiving the submission on April 11, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K971353 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1997
Decision Date May 12, 1997
Days to Decision 31 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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