510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K961623Substantially Equivalent

Facscomp Software & Calibrite 3 Color Beads Kit/calibrite Percp Beads

Becton Dickinson Monoclonal Center, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961623 is the FDA 510(k) clearance record for FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS, a class II device, cleared for Becton Dickinson Monoclonal Center on under FDA product code GKZ (Counter, Differential Cell). FDA records list one 510(k) clearance for Becton Dickinson Monoclonal Center. As of , FDA records show no recalls naming K961623.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Becton Dickinson Monoclonal Center 2350 Qume Dr., San Jose CA
510(k) summary
Summary
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