THYROXINE RADIOIMMUNOASSAY KIT— 510(k) K801105

Name: FDA 510(k) clearance K801105
Creator: U.S. Food and Drug Administration
Published: 1980-06-09

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K801105 for THYROXINE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1980-06-09. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1980-05-09
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

view all

K961490 — ELECSYS T4 ASSAY1996-06-13
K954312 — ACTIVE THYROXINE RIA1995-10-07
K943416 — DELFIA NEONATAL THYROXINE KIT1995-03-10
K934384 — AXSYM(TM) TOTAL T41994-06-21
K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

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.