IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT— 510(k) K963048

Name: FDA 510(k) clearance K963048
Creator: U.S. Food and Drug Administration
Published: 1996-11-04

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K963048 for IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT, Substantially Equivalent on 1996-11-04. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1996-08-06
Decision date: 1996-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DHR

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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 Beckman Instruments, Inc.

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Recalls naming K963048

K-number listed on FDA's recall record

Z-0003-2013 — IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.Class II·Terminated·Beckman Coulter Inc.·20120127

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963048.

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