510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K102064Substantially Equivalent

Bd Facs Sample Prep Assistant III (Spa III)

Becton Dickinson & Co, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102064 is the FDA 510(k) clearance record for BD FACS SAMPLE PREP ASSISTANT III (SPA III), a class II device, cleared for Becton, Dickinson & CO on under FDA product code GKZ (Counter, Differential Cell). FDA records list 345 510(k) clearances for Becton, Dickinson & CO, from to . As of , FDA records show no recalls naming K102064.

Clearance record

Decision date
Received
(227 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Becton, Dickinson & CO 2350 Qume Dr., San Jose CA
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