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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gbs culture media, selective and differential
510(k) Number K163042
Device Name chromID Strepto B agar
Applicant
bioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Applicant Contact Karen Russell
Correspondent
bioMerieux, Inc.
595 Anglum Road
Hazelwood,  MO  63042
Correspondent Contact Karen Russell
Regulation Number866.2360
Classification Product Code
PQZ  
Date Received10/31/2016
Decision Date 01/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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