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PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

by iXensor Co., Ltd. 2 variants

510(k) K192369

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK192369 Date29 Oct 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LCP
FDA applicant
Ixensor Co, Ltd.
Device Class
Class II
Regulation
21 CFR Part 864.7470
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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