510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091714Substantially Equivalent

Alcodigital Breathalyzer, Model At576, At577, At578, At579

Skyfine Inc. Limited, Taipei County, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091714 is the FDA 510(k) clearance record for ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579, a class I device, cleared for Skyfine Inc. Limited on under FDA product code DJZ (Devices, Breath Trapping, Alcohol). FDA records list one 510(k) clearance for Skyfine Inc. Limited. As of , FDA records show no recalls naming K091714.

Clearance record

Decision date
Received
(161 days to decision)
Product code
DJZ Devices, Breath Trapping, Alcohol
Regulation
21 CFR 862.3050
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Skyfine Inc. Limited #45, Minsheng Rd., Danshui, Taipei County, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DJZ

Trailing 12 months

FDA records hold no clearances under product code DJZ in the trailing twelve months.

FDA records show no clearances under product code DJZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DJZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260