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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 K850856
Device Name ICS THEOPHYLLINE REAGENTS
Applicant
Beckman Instruments, Inc.
2500 Harbor Blvd.
P.O. Box 3100
Fullerton,  CA  92634
Applicant Contact JACK E SOROKIN
Correspondent
Beckman Instruments, Inc.
2500 Harbor Blvd.
P.O. Box 3100
Fullerton,  CA  92634
Correspondent Contact JACK E SOROKIN
Regulation Number862.3880
Classification Product Code
KLS  
Date Received03/01/1985
Decision Date 03/29/1985
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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