510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780734Substantially Equivalent

Anticonvulsants II Calibrator Kit

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

K780734 is the FDA 510(k) clearance record for ANTICONVULSANTS II CALIBRATOR KIT, a class II device, cleared for Vitek Systems, Inc. on under FDA product code DIY (Gas Chromatography, Ethosuximide). FDA records list 39 510(k) clearances for Vitek Systems, Inc., from to . As of , FDA records show no recalls naming K780734.

Clearance record

Decision date
Received
(51 days to decision)
Product code
DIY Gas Chromatography, Ethosuximide
Regulation
21 CFR 862.3380
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Vitek Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DIY

Trailing 12 months

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

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