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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 K254167
Device Name MDx-Chex for BCY
Applicant
Streck, LLC
7002 S 109th St.
La Vista,  NE  68128
Applicant Contact Megan Hiveley
Correspondent
Streck, LLC
7002 S 109th St.
La Vista,  NE  68128
Correspondent Contact Megan Hiveley
Regulation Number866.3920
Classification Product Code
PMN  
Date Received12/23/2025
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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