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510(k) K772111

Device
IN VITRO PHENOBARBITAL RIA TEST
Applicant
CLINICAL ASSAYS, INC.
510(k) number
K772111
Product code
DKP  
Decision
Substantially Equivalent (SESE)
Decision date
1977-11-28
Date received
1977-11-07
Regulation
862.3660
Classification name
Radioimmunoassay, Phenobarbital
Medical specialty
Toxicology
Review panel
Immunology
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)DeviceApplicantDecision date
K844167ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KITBd Becton Dickinson Vacutainer Systems Preanalytic1984-11-27
K800090FLUOROMATIC PHENOLBARBITAL FIABio-Rad1980-01-23

Legacy Summary#

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FDA Review#

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