Cleared Traditional

SEALITE SCIENCES AQUALITE FSH

K970085 · Sealite Sciences, Inc. · Chemistry
Feb 1997
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K970085 is an FDA 510(k) clearance for the SEALITE SCIENCES AQUALITE FSH, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on February 14, 1997, 35 days after receiving the submission on January 10, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K970085 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1997
Decision Date February 14, 1997
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGJ — Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1300

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