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510(k) K903924

Device
BIOTRACK THEOPHYLLINE QUALITY CONTROLS
Applicant
BIOTRACK, INC.
510(k) number
K903924
Product code
LAW  
Decision
Substantially Equivalent (SESE)
Decision date
1990-09-17
Date received
1990-08-24
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
JILL FINDLAY
Address
1058 Huff Ave. Mountain View CA US 94043 94043

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
K871589THEOPHYLLINE FPIA CONTROLSSigma Chemical Co.1987-06-17

Legacy Summary#

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FDA Review#

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