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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Clostridium Difficile Toxin
510(k) Number K193490
Device Name SensiTox C. difficile Toxin Test
Applicant
First Light Diagnostics, Inc.
2 Omni Way
Chelmsford,  MA  01824
Applicant Contact Joanne Spadoro
Correspondent
MDC Associates, LLC
180 Cabot St.
Beverly,  MA  01915
Correspondent Contact Fran White
Regulation Number866.2660
Classification Product Code
LLH  
Date Received12/17/2019
Decision Date 07/08/2021
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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