510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895484Substantially Equivalent

Stratus(r) Gentamicin Fluorometric Enzyme Immuno.

Baxter Healthcare Corporation, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895484 is the FDA 510(k) clearance record for STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO., a class II device, cleared for Baxter Healthcare Corp on under FDA product code LCD (Enzyme Immunoassay, Gentamicin). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K895484.

Clearance record

Decision date
Received
(23 days to decision)
Product code
LCD Enzyme Immunoassay, Gentamicin
Regulation
21 CFR 862.3450
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Baxter Healthcare Corp P.O.Box 520672, Miami FL
Third party review
No

Clearances, product code LCD

Trailing 12 months

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

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