510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K960702Substantially Equivalent

Crp-Latex Seiken Xr Reagent System

Globe Management Support, Inc., Chuo-Ku, Tokyo 103, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960702 is the FDA 510(k) clearance record for CRP-LATEX SEIKEN XR REAGENT SYSTEM, a class II device, cleared for Globe Management Support, Inc. on under FDA product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control). FDA records list 2 510(k) clearances for Globe Management Support, Inc. As of , FDA records show no recalls naming K960702.

Clearance record

Decision date
Received
(59 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
Globe Management Support, Inc. 12-1 Nihonbashi, Kabuto-Cho, Chuo-Ku, Tokyo 103, JP
510(k) summary
Summary
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