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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Influenza Virus A, B, C
510(k) Number K003204
Device Name BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
Applicant
Intracel Corp.
1330 Piccard Dr.
Rockville,  MD  20850
Applicant Contact SHANE WARD
Correspondent
Intracel Corp.
1330 Piccard Dr.
Rockville,  MD  20850
Correspondent Contact SHANE WARD
Regulation Number866.3330
Classification Product Code
GNW  
Date Received10/13/2000
Decision Date 11/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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