TOTAL RADIOIMMUNOASSAY KIT— 510(k) K821101

Substantially Equivalent

Bioclinical Group

FDA 510(k) clearance K821101 for TOTAL RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1982-05-05. Applicant: Bioclinical Group. Device class: 2.

Clearance details

Applicant: Bioclinical Group
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1982-04-20
Decision date: 1982-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

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 Bioclinical Group

K862968 — FREE T3 RADIOIMMUNOASSAY KIT1986-09-25
K853837 — LH/FSH RADIOIMMUNOASSAY KIT1985-10-16
K832638 — CORTISOL RADIOIMMUNOASSAY KIT1983-09-12
K823005 — BIO MAG FREE T4 RADIOIMMUNOASSAY KIT1982-12-15
K823004 — BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT1982-11-05

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