Cleared Traditional

SPOTCHEM II CREATININE, AMYLASE & ALP TESTS

K050652 · Arkray, Inc. · Chemistry
Apr 2005
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K050652 is an FDA 510(k) clearance for the SPOTCHEM II CREATININE, AMYLASE & ALP TESTS, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on April 6, 2005, 23 days after receiving the submission on March 14, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K050652 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2005
Decision Date April 06, 2005
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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