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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Urine
510(k) Number K873086
Device Name ROUND 1
Applicant
Bioclinical Systems, Inc.
9130-B Guilford Rd.
Columbia,  MD  21046
Applicant Contact JOHN H POWERS
Correspondent
Bioclinical Systems, Inc.
9130-B Guilford Rd.
Columbia,  MD  21046
Correspondent Contact JOHN H POWERS
Regulation Number866.2660
Classification Product Code
JXA  
Date Received08/06/1987
Decision Date 08/24/1987
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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