FDA.reportPublic FDA data

510(k) K842921

Device
REES & ECKER DILUTION FLUID
Applicant
E K IND., INC.
510(k) number
K842921
Product code
GLG  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-07
Date received
1984-07-25
Regulation
864.6160
Classification name
Platelet Counting, Manual
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GLG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K811084LABTRONIX PLATELET COUNTER(L/O/C.)Labtronix Corp.1981-07-23
K772105PLATELET KITStreck Laboratories, Inc.1977-11-30

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