510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934003Substantially Equivalent

Stratus Digoxin Flourometric Enzyme Immunoassay

Baxter Diagnostics, Inc., Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934003 is the FDA 510(k) clearance record for STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY, a class II device, cleared for Baxter Diagnostics, Inc. on under FDA product code DKA (Antiserum, Digoxin). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K934003.

Clearance record

Decision date
Received
(462 days to decision)
Product code
DKA Antiserum, Digoxin
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Baxter Diagnostics, Inc. Scientific Products Div., Mcgaw Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code DKA

Trailing 12 months

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

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