Cleared Traditional

CARESIDE CALCIUM, ORIGINAL

K983789 · Careside, Inc. · Chemistry
Dec 1998
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K983789 is an FDA 510(k) clearance for the CARESIDE CALCIUM, ORIGINAL, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on December 17, 1998, 51 days after receiving the submission on October 27, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K983789 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1998
Decision Date December 17, 1998
Days to Decision 51 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