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Iq 200 Urine Analyzer Body Fluids Module

by Iris International, Inc. 510(k)

Active United States

510(k) K050235

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050235 Date23 Mar 2005ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GKL
Device Class
Class II
Regulation
21 CFR Part 864.5200
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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