510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011958Substantially Equivalent

Crp-Latex (II) Seiken High Sensitivity Assay Kit

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

K011958 is the FDA 510(k) clearance record for CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT, a class II device, cleared for Denka Seiken'S on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list 4 510(k) clearances for Denka Seiken'S, from to . As of , FDA records show no recalls naming K011958.

Clearance record

Decision date
Received
(165 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
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 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