510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864342Substantially Equivalent

Multipurpose Immunochemistry System La-2000 Latex

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

K864342 is the FDA 510(k) clearance record for MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX, a class II device, cleared for Eiken Chemical Co., Inc. on under FDA product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)). FDA records list 4 510(k) clearances for Eiken Chemical Co., Inc., from to . As of , FDA records show no recalls naming K864342.

Clearance record

Decision date
Received
(27 days to decision)
Product code
CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Eiken Chemical Co., Inc. 2004 Walnut Ave., Venice CA
Third party review
No

Clearances, product code CFN

Trailing 12 months

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

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