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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 K201403
Device Name NATtrol BD MAX Vaginal Panel External Controls
Applicant
Zeptometrix
878 Main St.
Buffalo,  NY  14202
Applicant Contact Shawn Smith
Correspondent
MDC Associates, Inc.
180 Cabot St.
Beverly,  MA  01915
Correspondent Contact Michael Smith
Regulation Number866.3920
Classification Product Code
PMN  
Date Received05/28/2020
Decision Date 02/02/2022
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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