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Irispec Urine Chemistry Control Part a and B

by International Remote Imaging Systems

510(k) K945913

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK945913 Date5 Apr 1995ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2124-2012 FDA Class III initiated 9 Jul 2012

    The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.

    • Terminated Z-0884-05 FDA Unclassified (pre-2012) initiated 29 Apr 2005

    Nonconformance to performance specifications.

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  • Withdrawn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
JJW
Device Class
Class I
Regulation
21 CFR Part 862.1660
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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