510(k) clearances

Endox Test Strips

Ibt Scientific · General Hospital

K263267Substantially EquivalentTraditionalJOJ
Open FDA's page for this record
Third party flag
N
City
Creedmoor
Advisory committee description
General Hospital
Address 1
1178 Telecom Dr.
Statement or summary
Summary
Product code
JOJ
Zip code
27522
Applicant
Ibt Scientific
Decision date
2026-10-16
Decision code
SESE
Country code
US
Device name
Endox Test Strips
Advisory committee
HO
Contact
Krystina Ashe
K number
K263267
State
NC
Date received
2026-09-18
Review advisory committee
HO
Postal code
27522
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Indicator, Physical/Chemical Sterilization Process
Medical specialty description
General Hospital
Regulation number
880.2800
Device class
2
Registration number
1051614, 3010363542, 9610612, 3000268902, 3027234828, 3013298431, 3015392401, 2437780, 3042191618, 3005581832, 3014421917, 3030626857, 3011494162, 3036622014, 3017524825, 1450386, 3036679484, 3021361802, 3010864832, 1720499, 3043226252, 9611959, 3031982553, 2013736, 3004634710, 3001124136, 1941138, 1722021, 3004201548, 3038138452, 3003476474, 3031841433, 2150060, 3016678045, 3029802606, 1417592, 2424472, 3012421607, 3030733800, 3016426851 +89 more
FEI number
1051614, 3010363542, 3000268902, 3027234828, 3013298431, 3015392401, 3042191618, 3005581832, 3014421917, 3030626857, 3011494162, 2523865, 3036622014, 3017524825, 3036679484, 3021361802, 1720499, 3043226252, 1937223, 3031982553, 2013736, 3004634710, 3001124136, 1941138, 3004201548, 3038138452, 3003476474, 3031841433, 2150060, 1000137528, 3008875470, 3016678045, 3029802606, 1417592, 3006442872, 3002677549, 3012421607, 3030733800, 3016426851, 1319130 +89 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.