T-4 RIASSAY— 510(k) K854798

Substantially Equivalent

Ria Diagnostics

FDA 510(k) clearance K854798 for T-4 RIASSAY, Substantially Equivalent on 1986-01-15. Applicant: Ria Diagnostics. Device class: 2.

Clearance details

Applicant: Ria Diagnostics
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1985-12-02
Decision date: 1986-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, 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 Ria Diagnostics

K855033 — T-3 UPTAKE/RIASSAY1986-01-24
K852537 — T-3 RIASSAY1985-08-12
K810296 — DIGOXIN RIA ASSAY1981-02-19
K801691 — TSH RIASSAY1980-08-27
K792062 — THEOPHYLLINE RIASSAY1980-02-25

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