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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Syncytial Virus, Antigen, Antibody, Ifa
510(k) Number K912838
Device Name BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
Applicant
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact Scott Dennis
Correspondent
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact Scott Dennis
Regulation Number866.3480
Classification Product Code
LKT  
Date Received06/26/1991
Decision Date 09/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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