Cleared Traditional

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

K130685 · Hitachi Chemical Diagnostics, Inc. · Chemistry
Aug 2013
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K130685 is an FDA 510(k) clearance for the HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on August 9, 2013, 149 days after receiving the submission on March 13, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K130685 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2013
Decision Date August 09, 2013
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFJ — Catalytic Methods, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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