510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925452Substantially Equivalent

Dade Hepzyme

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

K925452 is the FDA 510(k) clearance record for DADE HEPZYME, a class II device, cleared for Baxter Diagnostics, Inc. on under FDA product code JBR (Test, Heparin Neutralization). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K925452.

Clearance record

Decision date
Received
(75 days to decision)
Product code
JBR Test, Heparin Neutralization
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Applicant
Baxter Diagnostics, Inc. 1851 Delaware Pkwy., Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code JBR

Trailing 12 months

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

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