510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K102644Substantially Equivalent

Advia 2120 with Autoslide System, and Advia 2120I

Siemens Healthcare Diagnostics Inc., Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102644 is the FDA 510(k) clearance record for ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I, a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code GKZ (Counter, Differential Cell). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show 21 recalls naming K102644.

Clearance record

Decision date
Received
(435 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Siemens Healthcare Diagnostics 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 October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260