FDA.reportPublic FDA data

510(k) K873401

Device
TURBOX
Applicant
UNIPATH LTD.
510(k) number
K873401
Product code
JZW  
Decision
Substantially Equivalent (SESE)
Decision date
1987-09-23
Date received
1987-08-24
Regulation
866.4540
Classification name
Nephelometer
Medical specialty
Immunology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GEORGE ZAJICEK
Address
Norse Rd. Bedford Mk41 Oqg GB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JZW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001647BN PROSPEC SYSTEMDade Behring, Inc.2000-09-26
K761234BEHRING LASER NEPHELOMETERBehring Diagnostics, Inc.1990-06-07
K892223BEHRING NEPHELOMETER 100Behring Diagnostics, Inc.1989-05-04
K873407RRT SYSTEM LASER REFLECTOMETER ANALYZERIncstar Corp.1987-09-23
K801949BCM-302 COLLIMATING CONE & COMPENSATINB C Medical , Ltd.1980-10-03
K801391DISC 120 TRANSPORTERTravenol Laboratories, S.A.1980-07-14
K792014LANCER L-INA BUFFER, POLYMER, WASH SOLUSherwood Medical Industries1979-11-13
K781006IMMUNOCHEMISTRY SYS. MANUAL MODEBeckman Instruments, Inc.1978-08-31
K761235LASER STANDARD SERUMBehring Diagnostics, Inc.1976-12-30
K761236ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR.Behring Diagnostics, Inc.1976-12-30

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases