Cleared Traditional

COMPLETE D 25-OH VITAMIN D CONTROL

K113177 · Quantimetrix Corp. · Chemistry
May 2012
Decision
195d
Days
Class 1
Risk

About This 510(k) Submission

K113177 is an FDA 510(k) clearance for the COMPLETE D 25-OH VITAMIN D CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on May 10, 2012, 195 days after receiving the submission on October 28, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K113177 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2011
Decision Date May 10, 2012
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

Similar Devices — JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 492
Beta-CrossLaps CalCheck 5
K170678 · Roche Diagnostics · Apr 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173 · Roche Diagnostics · Jan 2017
Multichem A1c
K162514 · Technopath Manufacturing · Oct 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874 · Aalto Scientific, Ltd. · Aug 2016
LIAISON EBV IgM Serum Control Set
K161522 · DiaSorin, Inc. · Jun 2016
LIAISON CMV IgM Serum Control Set
K161526 · DiaSorin, Inc. · Jun 2016