510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K911626Substantially Equivalent

System 9000, Interpretive Diff Cell Counter

Serono Baker Diagnostics System, Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911626 is the FDA 510(k) clearance record for SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER, a class II device, cleared for Serono Baker Diagnostics System on under FDA product code GKZ (Counter, Differential Cell). FDA records list one 510(k) clearance for Serono Baker Diagnostics System. As of , FDA records show no recalls naming K911626.

Clearance record

Decision date
Received
(155 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Serono Baker Diagnostics System 100 Cascade Dr., Allentown PA
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