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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
Contact judi smith
Regulation Number866.3740
Classification Product Code
NJR  
Date Received07/29/2002
Decision Date 11/18/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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