T4-RIA KIT— 510(k) K780707

Substantially Equivalent

Clinical Bioresearch

FDA 510(k) clearance K780707 for T4-RIA KIT, Substantially Equivalent on 1978-06-14. Applicant: Clinical Bioresearch. Device class: 2.

Clearance details

Applicant: Clinical Bioresearch
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1978-04-25
Decision date: 1978-06-14
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 Clinical Bioresearch

K780499 — CBR-T3RIA KIT1978-05-04
K780500 — CBR-T3 UPTAKE KIT1978-05-03
K780498 — CBR-DIGOXIN ANTISERUM1978-04-05

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