FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101— 510(k) K874623

Name: FDA 510(k) clearance K874623
Creator: U.S. Food and Drug Administration
Published: 1988-02-16

Substantially Equivalent

Cyberfluor, Inc.

FDA 510(k) clearance K874623 for FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101, Substantially Equivalent on 1988-02-16. Applicant: Cyberfluor, Inc.. Device class: 2.

Clearance details

Applicant: Cyberfluor, Inc.
Product code: Product code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1987-11-10
Decision date: 1988-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

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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

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K904539 — FLAGEN TM FREE T41990-11-30
K900621 — FIAGEN(TM) HLH.S1990-03-01
K895186 — FIAGEN T3 UPTAKE CATALOGUE #101-4021989-11-08

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