FIAGEN T3 UPTAKE CATALOGUE #101-402— 510(k) K895186

Name: FDA 510(k) clearance K895186
Creator: U.S. Food and Drug Administration
Published: 1989-11-08

Substantially Equivalent

Cyberfluor, Inc.

FDA 510(k) clearance K895186 for FIAGEN T3 UPTAKE CATALOGUE #101-402, Substantially Equivalent on 1989-11-08. Applicant: Cyberfluor, Inc.. Device class: 2.

Clearance details

Applicant: Cyberfluor, Inc.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1989-08-11
Decision date: 1989-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHQ

view all

K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS1998-06-10
K980088 — T-UPTAKE MICROPLATE EIA1998-02-04
K970539 — CHIRON DIAGNOSTICS ACS:180TU P1997-03-24
K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)1996-11-27
K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

More clearances from Cyberfluor, Inc.

view all

K923410 — FIAGEN PROGESTERONE1992-12-03
K905656 — FLAGEN TRIIODOTHYRONINE (T3) ASSAY1991-01-23
K904539 — FLAGEN TM FREE T41990-11-30
K900621 — FIAGEN(TM) HLH.S1990-03-01
K895396 — CYBERFLUOR FIAGEN TSH1989-10-31

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