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
K853391Substantially Equivalent

Multipurpose Immunochemistry Sys-La-2000

Eiken Chemical Co., Ltd., Venice CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853391 is the FDA 510(k) clearance record for MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000, a class I device, cleared for Eiken Chemical Co., Inc. on under FDA product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use). FDA records list 4 510(k) clearances for Eiken Chemical Co., Inc., from to . As of , FDA records show no recalls naming K853391.

Clearance record

Decision date
Received
(49 days to decision)
Product code
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation
21 CFR 862.2160
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Eiken Chemical Co., Inc. 2004 Walnut Ave., Venice CA
Third party review
No

Clearances, product code JJE

Trailing 12 months

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

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