Cleared Special

TOTAL PROTEIN URINE/CSF GEN.3

K141925 · Roche Diagnostics Operations (Rdo) · Chemistry

Dec 2014

Decision

146d

Days

Class 1

Risk

About This 510(k) Submission

K141925 is an FDA 510(k) clearance for the TOTAL PROTEIN URINE/CSF GEN.3, a Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIQ), submitted by Roche Diagnostics Operations (Rdo) (Indianapolos, US). The FDA issued a Cleared decision on December 9, 2014, 146 days after receiving the submission on July 16, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number	K141925 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2014
Decision Date	December 09, 2014
Days to Decision	146 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	JIQ — Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1645