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510(k) K102338

BREATHSCN PRO by Akers Biosciences, Inc. — Product Code DJZ

K102338 is an FDA 510(k) premarket notification submitted by Akers Biosciences, Inc. for the device "BREATHSCN PRO". The FDA issued a decision of Substantially Equivalent on January 12, 2011. The device falls under product code DJZ (Devices, Breath Trapping, Alcohol), a Class I device regulated under 21 CFR 862.3050. Akers Biosciences, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2011
Date Received
August 18, 2010
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 Akers Biosciences, Inc.

  • K062971 — BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS (December 18, 2006)
  • K060761 — BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS (April 28, 2006)
  • K052697 — HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL (January 4, 2006)
  • K050338 — MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (March 4, 2005)

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)
  • 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)
  • K090067 — BACTRACK SELECT BREATHALYZER, MODEL S80 (March 24, 2009)

FDA data resources