510(k) K800090

Device: Fluoromatic Phenolbarbital Fia
Applicant: BIO-RAD
510(k) number: K800090
Product code: DKP
Decision: Substantially Equivalent (SESE)
Decision date: 1980-01-23
Date received: 1980-01-14
Regulation: 862.3660
Classification name: Radioimmunoassay, Phenobarbital
Medical specialty: Clinical Toxicology
Review panel: Clinical Toxicology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

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

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)	Device	Applicant	Decision date
K844167	ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1984-11-27
K772111	IN VITRO PHENOBARBITAL RIA TEST	Clinical Assays, Inc.	1977-11-28