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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K263267
Device Name Endox Test Strips
Applicant
Ibt Scientific
1178 Telecom Dr.
Creedmoor,  NC  27522
Applicant Contact Krystina Ashe
Correspondent
Ibt Scientific
1178 Telecom Dr.
Creedmoor,  NC  27522
Correspondent Contact Krystina Ashe
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received09/18/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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