510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915465Substantially Equivalent

Digitoxin Fpia Reagent Set

Sigma Diagnostics, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915465 is the FDA 510(k) clearance record for DIGITOXIN FPIA REAGENT SET, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code LFM (Enzyme Immunoassay, Digitoxin). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K915465.

Clearance record

Decision date
Received
(56 days to decision)
Product code
LFM Enzyme Immunoassay, Digitoxin
Regulation
21 CFR 862.3300
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code LFM

Trailing 12 months

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

FDA records show no clearances under product code LFM in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260