510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030545Substantially Equivalent

Crp-Latex (Ii)x2 Seiken Assay Kit

Denka Seiken Co., Ltd., Gosen City, Niigata, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030545 is the FDA 510(k) clearance record for CRP-LATEX (II)X2 SEIKEN ASSAY KIT, a class II device, cleared for Denka Seiken Co., Ltd. on under FDA product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control). FDA records list 6 510(k) clearances for Denka Seiken Co., Ltd., from to . As of , FDA records show one recall naming K030545.

Clearance record

Decision date
Received
(102 days to decision)
Product code
DCK C-Reactive Protein, Antigen, Antiserum, And Control
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Denka Seiken Co., Ltd. Kagamida Facility, Gosen City, Niigata, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DCK

Trailing 12 months

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

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