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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Endox Test Strips

FDA 510(k) source

510(k) number
K263267
Applicant
Ibt Scientific
Decision date
Oct 16, 2026
Date received
Sep 18, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
JOJ
Device type
Indicator, Physical/Chemical Sterilization Process
Device class
Class II
Regulation
21 CFR 880.2800
Advisory committee
General Hospital
Statement or summary
Summary
Third party
N
Location
Creedmoor, NC, US