Cleared Traditional

RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II

K922904 · Reagents Applications, Inc. · Chemistry
Jul 1992
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K922904 is an FDA 510(k) clearance for the RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on July 30, 1992, 44 days after receiving the submission on June 16, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K922904 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1992
Decision Date July 30, 1992
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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