510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013359Substantially Equivalent

Lp(a)-Latex Seiken Assay Kit

Denka Seiken'S, Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013359 is the FDA 510(k) clearance record for LP(A)-LATEX SEIKEN ASSAY KIT, a class II device, cleared for Denka Seiken'S on under FDA product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control). FDA records list 4 510(k) clearances for Denka Seiken'S, from to . As of , FDA records show no recalls naming K013359.

Clearance record

Decision date
Received
(149 days to decision)
Product code
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Regulation
21 CFR 866.5600
Device class
Class II
Review panel
Immunology
Applicant
Denka Seiken'S 3-4-2 Nihonbashi, Tokyo, JP
510(k) summary
Summary
Third party review
No

Clearances, product code DFC

Trailing 12 months
1 clearance under product code DFC in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DFC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260