510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953840Substantially Equivalent

Axsym Phenytoin II

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953840 is the FDA 510(k) clearance record for AXSYM PHENYTOIN II, a class II device, cleared for Abbott Laboratories on under FDA product code LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K953840.

Clearance record

Decision date
Received
(40 days to decision)
Product code
LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code LGR

Trailing 12 months

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

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