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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay, Primidone
510(k) Number K904683
Device Name STRATUS PRIMIDONE FLUOROMETRIC ENZYME
Applicant
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Applicant Contact A HORNBAKER
Correspondent
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Correspondent Contact A HORNBAKER
Regulation Number862.3680
Classification Product Code
LFT  
Date Received10/15/1990
Decision Date 11/28/1990
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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