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510(k) K920223

Device
CHEM CHEX THEOPHYLLINE CONTROL
Applicant
STRECK LABORATORIES, INC.
510(k) number
K920223
Product code
LAW  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-10
Date received
1992-01-17
Regulation
862.3280
Classification name
Theophylline Control Materials
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT M LACHOWIEZ
Address
14306 Industrial Rd. P.O. Box 37625 Omaha NE US 68144 68144

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LAW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914251MODEL IRC PASSPORT NEBULIZERInvacare Corp.1992-01-24
K903924BIOTRACK THEOPHYLLINE QUALITY CONTROLSBiotrack, Inc.1990-09-17
K871589THEOPHYLLINE FPIA CONTROLSSigma Chemical Co.1987-06-17

Legacy Summary#

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FDA Review#

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