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510(k) K871589

Device
THEOPHYLLINE FPIA CONTROLS
Applicant
SIGMA CHEMICAL CO.
510(k) number
K871589
Product code
LAW  
Decision
Substantially Equivalent (SESE)
Decision date
1987-06-17
Date received
1987-04-24
Regulation
862.3280
Classification name
Theophylline Control Materials
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DENNIS MURRAY
Address
P.O. Box 14508 St. Louis MO US 63178 63178

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LAW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920223CHEM CHEX THEOPHYLLINE CONTROLStreck Laboratories, Inc.1992-06-10
K914251MODEL IRC PASSPORT NEBULIZERInvacare Corp.1992-01-24
K903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSBiotrack, Inc.1990-09-17

Legacy Summary#

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FDA Review#

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