Cleared Special

TOTAL PROTEIN URINE/CSF GEN.3

K071239 · Roche Diagnostics · Chemistry
Sep 2007
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K071239 is an FDA 510(k) clearance for the TOTAL PROTEIN URINE/CSF GEN.3, a Turbidimetric, Total Protein (Class II — Special Controls, product code JGQ), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 14, 2007, 134 days after receiving the submission on May 3, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K071239 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2007
Decision Date September 14, 2007
Days to Decision 134 days
Submission Type Special
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

Similar Devices — JGQ Turbidimetric, Total Protein

All 12
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
K131051 · Hitachi Chemical Diagnostics, Inc. · Jun 2013
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · Roche Diagnostics Corp. · Oct 2007
UPRO
K981295 · Abbott Laboratories · Oct 1998
UPRO
K981682 · Abbott Laboratories · Sep 1998
TRACE MICROPROTEIN REAGENT
K925794 · Trace America, Inc. · Mar 1993
URINARY/CSF PROTEIN
K913615 · Boehringer Mannheim Corp. · Sep 1991