Cleared Traditional

HICHEM CALCIUM REAGENT KIT

K981794 · Hichem Diagnostics · Chemistry
Jul 1998
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K981794 is an FDA 510(k) clearance for the HICHEM CALCIUM REAGENT KIT, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on July 29, 1998, 69 days after receiving the submission on May 21, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K981794 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1998
Decision Date July 29, 1998
Days to Decision 69 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