ALCOMATE, MODEL CA2000— 510(k) K041334

Substantially Equivalent

Khn Solutions, LLC

FDA 510(k) clearance K041334 for ALCOMATE, MODEL CA2000, Substantially Equivalent on 2004-08-11. Applicant: Khn Solutions, LLC. Device class: 1.

Clearance details

Applicant: Khn Solutions, LLC
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2004-05-19
Decision date: 2004-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJZ

K160613 — Soberlink Cellular Device and Sober Sky Web Portal2016-07-14
K123470 — PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE2013-04-29
K110614 — PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM2011-11-21
K102225 — ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST2011-04-06
K102338 — BREATHSCN PRO2011-01-12

More clearances from Khn Solutions, LLC

K090067 — BACTRACK SELECT BREATHALYZER, MODEL S802009-03-24
K083801 — BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S702009-03-19
K071067 — BACTRACK LCD ALCOHOL DETECTOR2007-09-14

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