RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST— 510(k) K915320

Name: FDA 510(k) clearance K915320
Creator: U.S. Food and Drug Administration
Published: 1992-12-07

Substantially Equivalent

Trinity Laboratories, Inc.

FDA 510(k) clearance K915320 for RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST, Substantially Equivalent on 1992-12-07. Applicant: Trinity Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Trinity Laboratories, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1991-11-22
Decision date: 1992-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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