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510(k) K071067

BACTRACK LCD ALCOHOL DETECTOR by Khn Solutions, LLC — Product Code DJZ

K071067 is an FDA 510(k) premarket notification submitted by Khn Solutions, LLC for the device "BACTRACK LCD ALCOHOL DETECTOR". The FDA issued a decision of Substantially Equivalent on September 14, 2007. The device falls under product code DJZ (Devices, Breath Trapping, Alcohol), a Class I device regulated under 21 CFR 862.3050. Khn Solutions, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2007
Date Received
April 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices, Breath Trapping, Alcohol
Device Class
Class I
Regulation Number
862.3050
Review Panel
TX
Submission Type

Other clearances by Khn Solutions, LLC

  • K090067 — BACTRACK SELECT BREATHALYZER, MODEL S80 (March 24, 2009)
  • K083801 — BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 (March 19, 2009)
  • K041334 — ALCOMATE, MODEL CA2000 (August 11, 2004)

Other clearances for product code DJZ

  • K160613 — Soberlink Cellular Device and Sober Sky Web Portal (July 14, 2016)
  • K123470 — PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE (April 29, 2013)
  • K110614 — PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM (November 21, 2011)
  • K102225 — ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST (April 6, 2011)
  • K102338 — BREATHSCN PRO (January 12, 2011)
  • K100879 — CONTRALCO (August 4, 2010)
  • K093143 — MISSION BREATH ALCOHOL DETECTOR (January 28, 2010)
  • K091714 — ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (November 18, 2009)
  • K090766 — LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER (July 23, 2009)
  • K082080 — ALCO TUBE PLUS (April 1, 2009)

FDA data resources