510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823801Substantially Equivalent

Ames Tda Ethosuximide Test

Miles Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823801 is the FDA 510(k) clearance record for AMES TDA ETHOSUXIMIDE TEST, a class II device, cleared for Miles Laboratories, Inc. on under FDA product code DLF (Enzyme Immunoassay, Ethosuximide). FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from to . As of , FDA records show no recalls naming K823801.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DLF Enzyme Immunoassay, Ethosuximide
Regulation
21 CFR 862.3380
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Miles Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DLF

Trailing 12 months

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

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