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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name legionella, spp., elisa
510(k) Number K991074
Device Name BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
Applicant
INTRACEL CORP.
1330 PICCARD DR.
ROCKVILLE,  MD  20850
Applicant Contact SHERYL RUPPEL
Correspondent
INTRACEL CORP.
1330 PICCARD DR.
ROCKVILLE,  MD  20850
Correspondent Contact SHERYL RUPPEL
Regulation Number866.3300
Classification Product Code
MJH  
Date Received03/31/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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