Cleared Traditional

DSL ACTIVE HUMAN GROWTH HORMONE ELISA

K960551 · Diagnostic Systems Laboratories, Inc. · Chemistry
Mar 1996
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K960551 is an FDA 510(k) clearance for the DSL ACTIVE HUMAN GROWTH HORMONE 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 March 6, 1996, 27 days after receiving the submission on February 8, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K960551 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1996
Decision Date March 06, 1996
Days to Decision 27 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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