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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
510(k) Number K882596
Device Name MP TEST
Applicant
Diatech Diagnostica , Ltd.
1120 Vermont Ave., NW
Suite 600
Washington,  DC  20005
Applicant Contact MACKLER, PHD
Correspondent
Diatech Diagnostica , Ltd.
1120 Vermont Ave., NW
Suite 600
Washington,  DC  20005
Correspondent Contact MACKLER, PHD
Regulation Number866.3375
Classification Product Code
LJZ  
Date Received06/24/1988
Decision Date 06/21/1989
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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