RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST— 510(k) K962015

Name: FDA 510(k) clearance K962015
Creator: U.S. Food and Drug Administration
Published: 1996-11-25

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K962015 for RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST, Substantially Equivalent on 1996-11-25. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1996-05-22
Decision date: 1996-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHR

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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

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K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS2014-05-29
K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST2011-10-04
K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS2011-02-17

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