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510(k) K891761

Device
GDS ENZYMATIC THEOPHYLLINE REAGENT
Applicant
GDS DIAGNOSTICS
510(k) number
K891761
Product code
LCY  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-16
Date received
1989-03-24
Regulation
862.3880
Classification name
U.v. Spectrometry, Theophylline
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DE CASTRO
Address
25235 Leer Dr. P.O. Box 473 Elkhart IN US 46515 46515

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K780441THEOPHYLLINE ASSAY TO THE CENTRIFICHEMSyva Co.1978-04-12
K780442THEOPHYLLINE ASSAY TO THE GEMSAECSyva Co.1978-04-12

Legacy Summary#

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FDA Review#

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