MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX— 510(k) K864342

Name: FDA 510(k) clearance K864342
Creator: U.S. Food and Drug Administration
Published: 1986-12-01

Substantially Equivalent

Eiken Chemical Co., Inc.

FDA 510(k) clearance K864342 for MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX, Substantially Equivalent on 1986-12-01. Applicant: Eiken Chemical Co., Inc.. Device class: 2.

Clearance details

Applicant: Eiken Chemical Co., Inc.
Product code: Code CFN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1986-11-04
Decision date: 1986-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Venice, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFN

view all

K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)2023-12-13
K221114 — Immunoglobulin G (IgG)2023-08-02
K192116 — Human IgA liquid reagent kit for Use on SPAPlus2019-09-04
K191985 — Optilite IgA Kit2019-08-19
K191635 — Optilite IgM Kit2019-07-15

More clearances from Eiken Chemical Co., Inc.

view all

K853391 — MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-20001985-10-01

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