Cleared Special

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

K072638 · Roche Diagnostics Corp. · Chemistry
Oct 2007
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K072638 is an FDA 510(k) clearance for the ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801, a Turbidimetric, Total Protein (Class II — Special Controls, product code JGQ), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on October 19, 2007, 31 days after receiving the submission on September 18, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K072638 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2007
Decision Date October 19, 2007
Days to Decision 31 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