Cleared Traditional

AQUALITE INTACT PTH

K970483 · Sealite Sciences, Inc. · Chemistry
Apr 1997
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K970483 is an FDA 510(k) clearance for the AQUALITE INTACT PTH, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on April 14, 1997, 63 days after receiving the submission on February 10, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K970483 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1997
Decision Date April 14, 1997
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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