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510(k) K811775

Device
KALLESTAD ANTISERA TO PHENYTOIN
Applicant
KALLESTAD LABORATORIES, INC.
510(k) number
K811775
Product code
DLP  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-10
Date received
1981-06-23
Regulation
862.3350
Classification name
Radioimmunoassay, Diphenylhydantoin
Medical specialty
Toxicology
Review panel
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 DLP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K894527FPR PHENYTOIN KITColony Laboratories, Inc.1989-09-25
K792640FLUOROMATIC PHENYTOIN FIABio-Rad1980-01-11
K791896CENTRIA PHENYTOIN RIA TEST SETVentrex Laboratories, Inc.1979-10-17
K770779PHENYTOIN RIA KITAmersham Corp.1977-06-17

Legacy Summary#

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FDA Review#

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