Cleared Traditional

SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS

K053401 · Arkray, Inc. · Chemistry
Mar 2006
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K053401 is an FDA 510(k) clearance for the SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS, a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on March 24, 2006, 108 days after receiving the submission on December 6, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K053401 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2005
Decision Date March 24, 2006
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIC — Cresolphthalein Complexone, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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