Cleared Abbreviated

CHEMWELL, ALSO KNOWN AS PROJECT 2900

K013420 · Awareness Technology, Inc. · Chemistry
Jul 2002
Decision
277d
Days
Class 2
Risk

About This 510(k) Submission

K013420 is an FDA 510(k) clearance for the CHEMWELL, ALSO KNOWN AS PROJECT 2900, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on July 19, 2002, 277 days after receiving the submission on October 15, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K013420 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2001
Decision Date July 19, 2002
Days to Decision 277 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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