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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Vancomycin
510(k) Number K874438
Device Name STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
Applicant
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Applicant Contact KAREN H DARCY
Correspondent
Baxter Healthcare Corp
P.O. Box 520672
Miami,  FL  33152
Correspondent Contact KAREN H DARCY
Regulation Number862.3950
Classification Product Code
LEH  
Date Received10/28/1987
Decision Date 01/21/1988
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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