510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031377Substantially Equivalent

Sysmex Automated Coagulation Analyzer Ca500 Series (Ca-510, -520, -530, -540. -550, and -560

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031377 is the FDA 510(k) clearance record for SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560, 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 K031377.

Clearance record

Decision date
Received
(130 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. 500 Gbc Dr., Newark DE
510(k) summary
Summary PDF
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