510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K001145Substantially Equivalent

Sysmex Automated Coagulation Analyzer, Model Ca-6000

Siemens Healthcare Diagnostics Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001145 is the FDA 510(k) clearance record for SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000, a class II device, cleared for Dade Behring, Inc. on under FDA product code GKP (Instrument, Coagulation, Automated). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K001145.

Clearance record

Decision date
Received
(31 days to decision)
Product code
GKP Instrument, Coagulation, Automated
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Dade Behring, Inc. 7739 NW 48 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GKP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260