510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012824Substantially Equivalent

Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device

Acon Laboratories, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012824 is the FDA 510(k) clearance record for ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE, a class II device, cleared for ACON Laboratories, Inc. on under FDA product code DIS (Enzyme Immunoassay, Barbiturate). FDA records list 93 510(k) clearances for ACON Laboratories, Inc., from to . As of , FDA records show no recalls naming K012824.

Clearance record

Decision date
Received
(78 days to decision)
Product code
DIS Enzyme Immunoassay, Barbiturate
Regulation
21 CFR 862.3150
Device class
Class II
Review panel
Clinical Toxicology
Applicant
ACON Laboratories, Inc. 4108 Sorrento Valley Blvd., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code DIS

Trailing 12 months

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

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