ACTH IRMA KIT II MITSUBISHI YUKA— 510(k) K915727

Name: FDA 510(k) clearance K915727
Creator: U.S. Food and Drug Administration
Published: 1992-03-02

Substantially Equivalent

Mitsubishi Yuka America, Inc.

FDA 510(k) clearance K915727 for ACTH IRMA KIT II MITSUBISHI YUKA, Substantially Equivalent on 1992-03-02. Applicant: Mitsubishi Yuka America, Inc.. Device class: 2.

Clearance details

Applicant: Mitsubishi Yuka America, Inc.
Product code: Code CKG
Device class: Class 2
Regulation: 21 CFR 862.1025
Advisory panel: Clinical Chemistry
Date received: 1991-12-20
Decision date: 1992-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CKG

view all

K223867 — IDS ACTH II2023-08-18
K111335 — ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 0253212011-12-01
K060585 — ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH2006-05-03
K050748 — ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG0112005-05-20
K021032 — ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG1002002-06-03

More clearances from Mitsubishi Yuka America, Inc.

view all

K912536 — CALCITONIN KIT MITSUBISHI YUKA1991-07-18

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