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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K874456
Device Name CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT
Applicant
Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Applicant Contact THOMAS J MULDOON
Correspondent
Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Correspondent Contact THOMAS J MULDOON
Regulation Number866.2900
Classification Product Code
LIO  
Date Received10/28/1987
Decision Date 11/24/1987
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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