ACCUSCREEN T4— 510(k) K781222

Substantially Equivalent

Neometrics, Inc.

FDA 510(k) clearance K781222 for ACCUSCREEN T4, Substantially Equivalent on 1978-11-08. Applicant: Neometrics, Inc.. Device class: 2.

Clearance details

Applicant: Neometrics, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1978-07-17
Decision date: 1978-11-08
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 Neometrics, Inc.

K152560 — Bard Snare Retrieval Kit2015-10-23
K150225 — NovaGold High Performance Guidewire2015-03-16
K143135 — Spring Coil Guidewire2015-02-20
K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRE2014-02-20
K123439 — NEO ERCP GUIDEWIRE2013-01-03

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