Cleared Traditional

S-TEST CA

K072356 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Jun 2008
Decision
307d
Days
Class 2
Risk

About This 510(k) Submission

K072356 is an FDA 510(k) clearance for the S-TEST CA, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on June 24, 2008, 307 days after receiving the submission on August 22, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K072356 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2007
Decision Date June 24, 2008
Days to Decision 307 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

More from Alfa Wassermann Diagnostic...

View all
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
K131975 · CFJ · Oct 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K123953 · KHS · May 2013
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
K123018 · CFR · Apr 2013
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
K122757 · CHH · Oct 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · CDN · Aug 2012