DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR— 510(k) K922699

Name: FDA 510(k) clearance K922699
Creator: U.S. Food and Drug Administration
Published: 1992-09-23

Substantially Equivalent

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

FDA 510(k) clearance K922699 for DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR, Substantially Equivalent on 1992-09-23. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1992-06-04
Decision date: 1992-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIS

view all

K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR2012-08-14
K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR2006-05-31
K060266 — DIMENSION IRON CALIBRATOR2006-03-09
K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR2005-12-23
K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)2003-11-07

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.