Cleared Traditional

SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY

K972761 · Sealite Sciences, Inc. · Chemistry
Sep 1997
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K972761 is an FDA 510(k) clearance for the SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY, a Radioimmunoassay, Human Growth Hormone (Class I — General Controls, product code CFL), submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on September 25, 1997, 63 days after receiving the submission on July 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1370.

Submission Details

510(k) Number K972761 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1997
Decision Date September 25, 1997
Days to Decision 63 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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