510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963197Substantially Equivalent

On.site Alcohol

Ansys, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963197 is the FDA 510(k) clearance record for ON.SITE ALCOHOL, a class II device, cleared for Ansys, Inc. on under FDA product code DML (Nad-Nadh, Specific Reagent For Alcohol Enzyme Method). FDA records list one 510(k) clearance for Ansys, Inc. As of , FDA records show no recalls naming K963197.

Clearance record

Decision date
Received
(35 days to decision)
Product code
DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Regulation
21 CFR 862.3040
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ansys, Inc. 2 Goodyear, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code DML

Trailing 12 months

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

FDA records show no clearances under product code DML in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DML, 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