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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
510(k) Number K190086
Device Name Cepheid Xpert Respiratory Control Panel
Applicant
Microbiologics, Inc.
200 Cooper Avenue North
St. Cloud,  MN  56303
Applicant Contact Tina Sobania
Correspondent
Microbiologics, Inc.
200 Cooper Avenue North
St. Cloud,  MN  56303
Correspondent Contact Tina Sobania
Regulation Number866.3920
Classification Product Code
PMN  
Date Received01/17/2019
Decision Date 10/07/2019
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
Predetermined Change
Control Plan Authorized		 No
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