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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, All Mycoplasma Spp.
510(k) Number K883083
Device Name MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
Applicant
Medical Diagnostic Technologies, Inc.
3351 Wrightsboro Rd.
Suite 502
Augusta,  GA  30909
Applicant Contact DAVID A WALL
Correspondent
Medical Diagnostic Technologies, Inc.
3351 Wrightsboro Rd.
Suite 502
Augusta,  GA  30909
Correspondent Contact DAVID A WALL
Regulation Number866.3375
Classification Product Code
GSA  
Date Received07/21/1988
Decision Date 10/25/1988
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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