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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 K904501
Device Name MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM
Applicant
Medical Diagnostic Technologies, Inc.
3351 Wrightsboro Rd.
Suite 502
Augusta,  GA  30909
Applicant Contact HARWOOD STILES
Correspondent
Medical Diagnostic Technologies, Inc.
3351 Wrightsboro Rd.
Suite 502
Augusta,  GA  30909
Correspondent Contact HARWOOD STILES
Regulation Number866.3375
Classification Product Code
LJZ  
Date Received10/02/1990
Decision Date 02/26/1991
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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