510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813538Substantially Equivalent

Phenytoin Fluorescent Immunoassay

American Diagnostic Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813538 is the FDA 510(k) clearance record for PHENYTOIN FLUORESCENT IMMUNOASSAY, a class II device, cleared for American Diagnostic Corp. on under FDA product code LES (Fluorescent Immunoassay, Diphenylhydantoin). FDA records list 39 510(k) clearances for American Diagnostic Corp., from to . As of , FDA records show no recalls naming K813538.

Clearance record

Decision date
Received
(10 days to decision)
Product code
LES Fluorescent Immunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
American Diagnostic Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LES

Trailing 12 months

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

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