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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 K920212
Device Name MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM
Applicant
Shared Systems, Inc.
P.O. Box 211587
Martinez,  GA  30917
Applicant Contact ROBERT C HICKS
Correspondent
Shared Systems, Inc.
P.O. Box 211587
Martinez,  GA  30917
Correspondent Contact ROBERT C HICKS
Regulation Number866.3375
Classification Product Code
LJZ  
Date Received01/16/1992
Decision Date 08/20/1992
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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