510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K042251Substantially Equivalent

Bayer Advia 2120 Hematology Analyzer with Autoslide System

Medrad, Inc., Tarrytown NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042251 is the FDA 510(k) clearance record for BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM, a class II device, cleared for Bayer Healthcare, LLC on under FDA product code GKZ (Counter, Differential Cell). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show no recalls naming K042251.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Bayer Healthcare, LLC 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260
November 20260