FDA.reportPublic FDA data

510(k) K844167

Device
ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K844167
Product code
DKP  
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-27
Date received
1984-10-25
Regulation
862.3660
Classification name
Radioimmunoassay, Phenobarbital
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RUSSELL J ARNSBERGE
Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DKP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K800090FLUOROMATIC PHENOLBARBITAL FIABio-Rad1980-01-23
K772111IN VITRO PHENOBARBITAL RIA TESTClinical Assays, Inc.1977-11-28

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