Cleared Traditional

ELECSYS TOXO IGG CALCHECK 5

K092888 · Roche Diagnostics Corp. · Microbiology
Nov 2009
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K092888 is an FDA 510(k) clearance for the ELECSYS TOXO IGG CALCHECK 5, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on November 10, 2009, 50 days after receiving the submission on September 21, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K092888 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2009
Decision Date November 10, 2009
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
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