ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT— 510(k) K113435

Name: FDA 510(k) clearance K113435
Creator: U.S. Food and Drug Administration
Published: 2012-07-02

Substantially Equivalent

Alfa Wassermann

FDA 510(k) clearance K113435 for ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT, Substantially Equivalent on 2012-07-02. Applicant: Alfa Wassermann. Device class: 2.

Clearance details

Applicant: Alfa Wassermann
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2011-11-21
Decision date: 2012-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHS

view all

K170200 — Carbon Dioxide Reagent Set2017-06-01
K152085 — Liquid CO2-2 (LCO2-2)2016-02-24
K140248 — S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)2014-03-11
K131546 — AU BICARBONATE REAGENT2013-10-09
K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT2013-05-02

More clearances from Alfa Wassermann

view all

K131515 — ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT2013-08-14
K113382 — ACE ALT REAGENT2012-07-19
K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT2012-07-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.