Cleared Traditional

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)

K131051 · Hitachi Chemical Diagnostics, Inc. · Chemistry
Jun 2013
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K131051 is an FDA 510(k) clearance for the HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB), a Turbidimetric, Total Protein (Class II — Special Controls, product code JGQ), submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 7, 2013, 53 days after receiving the submission on April 15, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K131051 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2013
Decision Date June 07, 2013
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JGQ — Turbidimetric, Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635