RIA SYSTEM FOR HUMAN FE-RITIN— 510(k) K781527

Name: FDA 510(k) clearance K781527
Creator: U.S. Food and Drug Administration
Published: 1978-10-03

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K781527 for RIA SYSTEM FOR HUMAN FE-RITIN, Substantially Equivalent on 1978-10-03. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code JMG
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1978-09-05
Decision date: 1978-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JMG

view all

K234052 — Access Ferritin2024-03-20
K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 330202005-08-19
K964282 — TINA-QUANT FERRITIN ASSAY1997-07-30
K971833 — ELECSYS FERRITIN1997-06-02
K963498 — FERR FLEX REAGENT CARTRIDGE1997-01-24

More clearances from Calbiochem-Behring Corp.

view all

K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE1983-07-28
K831036 — ENA TEST KIT SM & RNP AUTO ANTIBODY1983-04-27
K830214 — AFT SYSTEM III1983-03-09
K820812 — CREATINE KINASE-MB KIT1982-04-12
K813493 — ENZYGNOST TM RUBELLA IGM1982-03-04

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