RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.— 510(k) K802448

Name: FDA 510(k) clearance K802448
Creator: U.S. Food and Drug Administration
Published: 1981-01-05

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K802448 for RA 80 EIKEN KIT DETERM. OF RHEUMATIC F., Substantially Equivalent on 1981-01-05. Applicant: Syn-Kit, Inc.. Device class: 2.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1980-10-08
Decision date: 1981-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Syn-Kit, Inc.

view all

K861098 — SEROIDEN STREPTO KIT 'EIKEN'1986-08-12
K861631 — SLIDE CULTURE U 'EIKEN'1986-06-10
K854819 — CPR SLIDE EIKEN1986-02-26
K854820 — RA 80 EIKEN1986-01-17
K853276 — ASO SLIDE EIKEN1985-08-20

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