510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130685Substantially Equivalent

Hitachi Clinical Analyzer S Test Reagent Cartridges for Ld and Amy

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

K130685 is the FDA 510(k) clearance record for HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY, a class II device, cleared for Hitachi Chemical Diagnostics, Inc. on under FDA product code JFJ (Catalytic Methods, Amylase). FDA records list 16 510(k) clearances for Canon Medical Diagnostics USA, Inc., from to . As of , FDA records show no recalls naming K130685.

Clearance record

Decision date
Received
(149 days to decision)
Product code
JFJ Catalytic Methods, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hitachi Chemical Diagnostics, Inc. 575 Shirlynn Ct., Los Angeles CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JFJ

Trailing 12 months

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

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