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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameShared Systems M. pneumoniae Rapid Latex  (Qualitative)
Document NumberK950073
Parent Document NumberK950073
Analyte NameMycoplasma pneumoniae antibodies
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date10/20/1995
Device Classification Name Antisera, All Mycoplasma Spp.
510(k) Number K950073
Device Name MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION 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
GSA  
Date Received01/09/1995
Decision Date 10/17/1995
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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