510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780461Substantially Equivalent

Analyzer-Supplement, Kinetic, Lkb 2086

Syva Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780461 is the FDA 510(k) clearance record for ANALYZER-SUPPLEMENT, KINETIC, LKB 2086, a class II device, cleared for Syva Co. on under FDA product code DLF (Enzyme Immunoassay, Ethosuximide). FDA records list 212 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K780461.

Clearance record

Decision date
Received
(20 days to decision)
Product code
DLF Enzyme Immunoassay, Ethosuximide
Regulation
21 CFR 862.3380
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Syva Co. 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