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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Theophylline
510(k) Number K911060
Device Name IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
Applicant
Immunomatrix
9027 Mistwood Dr.
Potomac,  MD  20854
Applicant Contact LANCE A LIOTTA
Correspondent
Immunomatrix
9027 Mistwood Dr.
Potomac,  MD  20854
Correspondent Contact LANCE A LIOTTA
Regulation Number862.3880
Classification Product Code
KLS  
Date Received03/11/1991
Decision Date 05/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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