Cleared Traditional

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)

K130870 · Hitachi Chemical Diagnostics, Inc. · Chemistry
May 2013
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K130870 is an FDA 510(k) clearance for the HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA), a Cresolphthalein Complexone, Calcium (Class II — Special Controls, product code CIC), submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 2, 2013, 34 days after receiving the submission on March 29, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K130870 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2013
Decision Date May 02, 2013
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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