510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113809Substantially Equivalent

Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (Crp)

Canon Medical Diagnostics USA, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113809 is the FDA 510(k) clearance record for HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP), a class II device, cleared for Hitachi Chemical Diagnostics, Inc. on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list 16 510(k) clearances for Canon Medical Diagnostics USA, Inc., from to . As of , FDA records show no recalls naming K113809.

Clearance record

Decision date
Received
(238 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Hitachi Chemical Diagnostics, Inc. 575 Shirlynn Ct., Los Angeles CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DCN

Trailing 12 months

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

FDA records show no clearances under product code DCN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DCN, 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