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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
510(k) Number K042357
Device Name IDI-MRSA ASSAY
Applicant
INFECTIO DIAGNOSTIC (I.D.I.) INC.
13801 ECK ROAD
HYDES,  MD  21082
Applicant Contact JUDITH SMITH
Correspondent
INFECTIO DIAGNOSTIC (I.D.I.) INC.
13801 ECK ROAD
HYDES,  MD  21082
Correspondent Contact JUDITH SMITH
Regulation Number866.1640
Classification Product Code
NQX  
Date Received08/31/2004
Decision Date 10/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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