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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer, For Clinical Use
510(k) Number K890908
Device Name STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 520672
MIAMI,  FL  33152
Applicant Contact JEANNE-MARIE VARGA
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 520672
MIAMI,  FL  33152
Correspondent Contact JEANNE-MARIE VARGA
Regulation Number862.2560
Classification Product Code
KHO  
Date Received02/23/1989
Decision Date 03/24/1989
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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