FDA.reportPublic FDA data

510(k) K033743

Device
COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
Applicant
COZART BIOSCIENCE LTD.
510(k) number
K033743
Product code
KZD  
Decision
Substantially Equivalent (SESE)
Decision date
2004-06-03
Date received
2003-11-28
Regulation
880.5420
Classification name
Infusor, Pressure, For I.v. Bags
Medical specialty
General Hospital
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERTO LIDDI
Address
45 Milton Park Abingdon,Oxfordshire GB OX14 4RU OX14 4RU

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KZD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.1998-02-17
K973843MSI PRESSURE INFUSORSmith Assoc.1997-10-29
K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.1995-10-07
K951988PRESSURIZERPromedic, Inc.1995-06-14
K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.1994-08-25
K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.1993-12-14
K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000Allen Medical Systems, Inc.1993-04-21
K913751PRESSURE INFUSERBiomedical Dynamics, Inc.1992-01-09
K910926TECNADYNE SURGI-SQUEEZE INFUSION PUMPTecnadyne Scientific, Inc.1991-08-02
K911216INFUSABLEBiomedical Dynamics, Inc.1991-07-22
K904484BAXTER SINGLE PATIENT USE PRESSURE INFUSORTecnadyne Scientific, Inc.1990-10-26
K901225LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)Abbott Laboratories1990-08-23
K894927SURGI SQUEEZEthox Corp.1989-09-11
K881977PRESSURE INFUSORPrimrose Medical, Inc.1988-07-29
K874454IV-PUSH, CONSTANT INFUSION PUMPMedical Products Search, Inc.1987-11-06

Legacy Summary#

summary

FDA Review#

Decision Summary