Cleared Traditional

SEALITE SCIENCES, INC. AQUALITE PROLACTIN

K970188 · Sealite Sciences, Inc. · Chemistry
Feb 1997
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K970188 is an FDA 510(k) clearance for the SEALITE SCIENCES, INC. AQUALITE PROLACTIN, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on February 20, 1997, 34 days after receiving the submission on January 17, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.

Submission Details

510(k) Number K970188 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1997
Decision Date February 20, 1997
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CFT — Radioimmunoassay, Prolactin (lactogen)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1625

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