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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K911712
Device Name STRATUS(R) AUTOMATED SAMPLE HANDLER
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 Number862.2750
Classification Product Code
JQW  
Date Received04/17/1991
Decision Date 05/15/1991
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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