FDA.reportPublic FDA data

510(k) K771523

Device
LATELET RETENTION COLUMN
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K771523
Product code
JBZ  
Decision
Substantially Equivalent (SESE)
Decision date
1977-11-22
Date received
1977-08-08
Regulation
864.6650
Classification name
Study, Platelet Adhesive
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JBZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K800037PLATELET RETENTION (ADHESION) COLUMNSHemometrix1980-02-05
K771678THROMBO-SCREEN PLATELET ADHESIONBay Area Hema. Onco. Clinic. & Res. L1977-11-22

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