Cleared Traditional

SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS

K050077 · Arkray, Inc. · Chemistry
Feb 2005
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K050077 is an FDA 510(k) clearance for the SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN 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 February 15, 2005, 34 days after receiving the submission on January 12, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K050077 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2005
Decision Date February 15, 2005
Days to Decision 34 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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