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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric, Cortisol
510(k) Number K895421
Device Name CORTISOL TEST SYSTEM
Applicant
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Applicant Contact NANCY A HORNBAKER
Correspondent
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Correspondent Contact NANCY A HORNBAKER
Regulation Number862.1205
Classification Product Code
JFT  
Date Received09/01/1989
Decision Date 12/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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