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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nucleic acid amplification assay system, group b streptococcus, direct specimen test
510(k) Number K022504
Device Name IDI-STREP B ASSAY
Applicant
INFECTIO DIAGNOSTIC, INC.
P.O. BOX 103
BALDWIN,  MD  21013
Applicant Contact Judi Smith
Correspondent
INFECTIO DIAGNOSTIC, INC.
P.O. BOX 103
BALDWIN,  MD  21013
Correspondent Contact Judi Smith
Regulation Number866.3740
Classification Product Code
NJR  
Date Received07/29/2002
Decision Date 11/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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