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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 K820126
Device Name RAPID BACTERIURIA SCREENING TEST
Applicant
Analytical Luminescence Laboratory, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Analytical Luminescence Laboratory, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2660
Classification Product Code
JXA  
Date Received01/18/1982
Decision Date 01/07/1983
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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