510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854392Substantially Equivalent

Tobramycin Kit(fpia)fluorescence Polarization Immu

Windsor Laboratories, Inc., Garland TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854392 is the FDA 510(k) clearance record for TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU, a class II device, cleared for Windsor Laboratories, Inc. on under FDA product code LFW (Fluorescence Polarization Immunoassay, Tobramycin). FDA records list 19 510(k) clearances for Windsor Laboratories, Inc., from to . As of , FDA records show no recalls naming K854392.

Clearance record

Decision date
Received
(35 days to decision)
Product code
LFW Fluorescence Polarization Immunoassay, Tobramycin
Regulation
21 CFR 862.3900
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Windsor Laboratories, Inc. P.O. Box 475487, Garland TX
Third party review
No

Clearances, product code LFW

Trailing 12 months

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

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