510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K960703Substantially Equivalent

RF-Latex Seiken Reagent System

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

K960703 is the FDA 510(k) clearance record for RF-LATEX SEIKEN REAGENT SYSTEM, a class II device, cleared for Globe Management Support, Inc. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 2 510(k) clearances for Globe Management Support, Inc. As of , FDA records show no recalls naming K960703.

Clearance record

Decision date
Received
(59 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
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 DHR

Trailing 12 months

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

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