510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904683Substantially Equivalent

Stratus Primidone Fluorometric Enzyme

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

K904683 is the FDA 510(k) clearance record for STRATUS PRIMIDONE FLUOROMETRIC ENZYME, a class II device, cleared for Baxter Healthcare Corp on under FDA product code LFT (Fluorescent Immunoassay, Primidone). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K904683.

Clearance record

Decision date
Received
(44 days to decision)
Product code
LFT Fluorescent Immunoassay, Primidone
Regulation
21 CFR 862.3680
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 LFT

Trailing 12 months

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

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