510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K964139Substantially Equivalent

Sysmex Ca-6000

Dade Intl., Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964139 is the FDA 510(k) clearance record for SYSMEX CA-6000, a class II device, cleared for Dade Intl., Inc. on under FDA product code GKP (Instrument, Coagulation, Automated). FDA records list 30 510(k) clearances for Dade Intl., Inc., from to . As of , FDA records show no recalls naming K964139.

Clearance record

Decision date
Received
(114 days to decision)
Product code
GKP Instrument, Coagulation, Automated
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Dade Intl., Inc. 9750 NW 25th St., Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code GKP

Trailing 12 months

FDA records hold no clearances under product code GKP in the trailing twelve months.

FDA records show no clearances under product code GKP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GKP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260