TIBC PRETREATMENT KIT— 510(k) K842019

Name: FDA 510(k) clearance K842019
Creator: U.S. Food and Drug Administration
Published: 1984-06-22

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K842019 for TIBC PRETREATMENT KIT, Substantially Equivalent on 1984-06-22. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JQE
Device class: Class 1
Regulation: 21 CFR 862.1415
Advisory panel: Clinical Chemistry
Date received: 1984-05-18
Decision date: 1984-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JQE

view all

K970248 — CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM1997-02-11
K934358 — KODAK EKTACHEM DT SLIDES (FE)1994-03-21
K910672 — J&S PEDIATRIC IRON SATURATING REAGENT1991-04-29
K884649 — TOTAL IRON BINDING CAPACITY TEST1988-12-14
K864548 — ALFERR TIBC TUBE1987-02-02

More clearances from E.I. Dupont DE Nemours & Co., Inc.

view all

K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY1996-07-24
K953724 — CRONEX RADIATION THERAPY CASSETTE1995-09-06
K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE1995-09-06
K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD1995-06-01
K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE1995-04-13

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