ENCORE RHEUMATOID FACTOR EIA— 510(k) K924056

Name: FDA 510(k) clearance K924056
Creator: U.S. Food and Drug Administration
Published: 1992-09-25

Substantially Equivalent

Clark Laboratories, Inc.

FDA 510(k) clearance K924056 for ENCORE RHEUMATOID FACTOR EIA, Substantially Equivalent on 1992-09-25. Applicant: Clark Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Clark Laboratories, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1992-08-12
Decision date: 1992-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blairstown, NJ, 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 Clark Laboratories, Inc.

view all

K980596 — VCA IGM ELISA TEST SYSTEM1998-07-22
K980912 — VCA IGG ELISA TEST SYSTEM1998-07-22
K980598 — EBNA-1 IGM ELISA TEST SYSTEM1998-05-01
K973123 — EA-D IGG ELISA TEST SYSTEM1998-03-26
K931543 — ENCORE ENA COMBINED EIA1993-09-08

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