FDA.reportPublic FDA data

510(k) K902572

Device
SODIUM REAGENT SET
Applicant
TECH INTL. CO.
510(k) number
K902572
Product code
CEI  
Decision
Substantially Equivalent (SESE)
Decision date
1990-07-10
Date received
1990-06-11
Regulation
862.1665
Classification name
Uranyl Acetate/zinc Acetate, Sodium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHEN, PH.D
Address
1856 Starr-Batt Dr. Rochester Hills MI US 48309 48309

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CEI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K043268SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2Randox Laboratories, Ltd.2005-02-15
K914039SODIUM REAGENT SETSterling Diagnostics, Inc.1991-10-31
K832552SODIUM TEST KITMallinckrodt Critical Care1983-09-20

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