CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM— 510(k) K953261

Name: FDA 510(k) clearance K953261
Creator: U.S. Food and Drug Administration
Published: 1995-08-15

Substantially Equivalent

Shared Systems, Inc.

FDA 510(k) clearance K953261 for CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM, Substantially Equivalent on 1995-08-15. Applicant: Shared Systems, Inc.. Device class: 2.

Clearance details

Applicant: Shared Systems, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1995-07-12
Decision date: 1995-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHR

view all

K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)2020-05-20
K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents2019-04-17
K182747 — EliA RF IgM Immunoassay2018-12-18
K162263 — Optilite Rheumatoid Factor Kit2017-05-03
K160070 — Rheumatoid Factor (RF) Kit for use on SPAPLUS2016-12-07

More clearances from Shared Systems, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.