RF-LATEX SEIKEN REAGENT SYSTEM— 510(k) K960703

Name: FDA 510(k) clearance K960703
Creator: U.S. Food and Drug Administration
Published: 1996-04-19

Substantially Equivalent

Globe Management Support, Inc.

FDA 510(k) clearance K960703 for RF-LATEX SEIKEN REAGENT SYSTEM, Substantially Equivalent on 1996-04-19. Applicant: Globe Management Support, Inc.. Device class: 2.

Clearance details

Applicant: Globe Management Support, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1996-02-20
Decision date: 1996-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuo-Ku, Tokyo 103, JP

Download summary PDF View on FDA.gov ↗

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