ANALYTE IRON/TECHNICON CHEM 1 SYSTEM— 510(k) K860799

Name: FDA 510(k) clearance K860799
Creator: U.S. Food and Drug Administration
Published: 1986-04-03

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K860799 for ANALYTE IRON/TECHNICON CHEM 1 SYSTEM, Substantially Equivalent on 1986-04-03. Applicant: Technicon Instruments Corp.. Device class: 1.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1986-03-04
Decision date: 1986-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIY

view all

K061793 — DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR2006-08-07
K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)2006-03-08
K051115 — SENTINEL IRON LIQUID2005-08-25
K033983 — VITALAB IRON REAGENT2004-05-21
K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)2003-06-17

More clearances from Technicon Instruments Corp.

view all

K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL1991-11-27
K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST)1991-11-27
K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P)1991-11-22
K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES1991-09-25
K912413 — CHEM-LINK DATA BASE MANAGER1991-07-01

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