Cleared Traditional

CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91

K051757 · Diagnostic Chemicals , Ltd. · Chemistry
Nov 2005
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K051757 is an FDA 510(k) clearance for the CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on November 10, 2005, 134 days after receiving the submission on June 29, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K051757 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2005
Decision Date November 10, 2005
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

Similar Devices — CJY Azo Dye, Calcium

All 46
Calcium2
K244042 · Abbott Ireland · Feb 2025
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K191396 · HORIBA ABX SAS · Jul 2019
Randox Calcium (Ca)
K182042 · Randox Laboratories, Ltd. · Oct 2018
ELITech Clinical Systems CALCIUM ARSENAZO
K151113 · Elitechgroup · Jul 2015
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
K123171 · HORIBA ABX SAS · Jul 2013
EON CALCIUM REGENT
K120626 · Vital Diagnostics (Manufacturing) Ptyltd · Aug 2012