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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 K915454
Device Name CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
Applicant
Medical Packaging Corp.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Applicant Contact JOYCE DAVIS
Correspondent
Medical Packaging Corp.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Correspondent Contact JOYCE DAVIS
Regulation Number866.2900
Classification Product Code
LIO  
Date Received12/05/1991
Decision Date 04/08/1992
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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