T4 RIA KIT— 510(k) K810811

Substantially Equivalent

Immuno Assay Corp.

FDA 510(k) clearance K810811 for T4 RIA KIT, Substantially Equivalent on 1981-04-07. Applicant: Immuno Assay Corp.. Device class: 2.

Clearance details

Applicant: Immuno Assay Corp.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1981-03-24
Decision date: 1981-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Immuno Assay Corp.

K833842 — RIA COAT DIGOXIN1984-01-17
K833745 — RIACOAT T-41984-01-04
K820074 — CORTISOL (RIA) KIT1982-01-28
K820089 — TSH (RIA) KIT1982-01-28
K811954 — COMBO-FER IRON DIAGNOSTIC1981-07-27

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