Cleared Traditional

CALCIUM GEN. 2

K113521 · Roche Diagnostics · Chemistry
May 2012
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K113521 is an FDA 510(k) clearance for the CALCIUM GEN. 2, a Titrimetric With Edta And Indicator, Calcium (Class II — Special Controls, product code CHW), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 8, 2012, 161 days after receiving the submission on November 29, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K113521 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2011
Decision Date May 08, 2012
Days to Decision 161 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHW — Titrimetric With Edta And Indicator, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145