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510(k) K813538

Device
PHENYTOIN FLUORESCENT IMMUNOASSAY
Applicant
AMERICAN DIAGNOSTIC CORP.
510(k) number
K813538
Product code
LES  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-31
Date received
1981-12-21
Regulation
862.3350
Classification name
Fluorescent Immunoassay, Diphenylhydantoin
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LES  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K865102IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTSSclavo, Inc.1987-01-13
K844990SYVA ADVANCE EMIT PHENYTOIN ASSAYSyva Co.1985-01-23
K831154STRATUS PHENYTOIN FLUOROMETRIC ENZYMEAmerican Dade1983-05-16
K820187SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENYSyva Co.1982-02-12
K811025AMES TDA TM PHENYTOIN TESTMiles Laboratories, Inc.1981-04-29
K801736AMES TDA TM PHENYTOIN TESTMiles Laboratories, Inc.1980-08-20

Legacy Summary#

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FDA Review#

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