Cleared Traditional

DELFIA NEONATAL THYROXINE KIT

K943416 · Wallac OY · Chemistry
Mar 1995
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K943416 is an FDA 510(k) clearance for the DELFIA NEONATAL THYROXINE KIT, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Wallac OY (Finland, FI). The FDA issued a Cleared decision on March 10, 1995, 238 days after receiving the submission on July 15, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K943416 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1994
Decision Date March 10, 1995
Days to Decision 238 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDX — Radioimmunoassay, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

Similar Devices — CDX Radioimmunoassay, Total Thyroxine

All 120
ELECSYS T4 ASSAY
K961490 · Boehringer Mannheim Corp. · Jun 1996
ACTIVE THYROXINE RIA
K954312 · Diagnostic Systems Laboratories, Inc. · Oct 1995
AXSYM(TM) TOTAL T4
K934384 · Abbott Laboratories · Jun 1994
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · Sigma Diagnostics, Inc. · Oct 1993
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
K933426 · Baxter Diagnostics, Inc. · Aug 1993
IQ TT4 ASSAY
K931295 · Becton Dickinson Advanced Diagnostics · Jul 1993