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Negative Control Strips for Urinalysis (Chex-Stix, Clinitek Auto 2000, Clinitex Atlas)

by Heraeus Kulzer, Inc.

510(k) K943780

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK943780 Date31 Oct 1994ClearedStatusActive

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0641-2013 FDA Class III initiated 21 Nov 2012
    • Terminated Z-0639-2013 FDA Class III initiated 21 Nov 2012
    • Terminated Z-0637-2013 FDA Class III initiated 21 Nov 2012
    • Terminated Z-0640-2013 FDA Class II initiated 21 Nov 2012
    • Terminated Z-0635-2013 FDA Class III initiated 21 Nov 2012
    • Terminated Z-0636-2013 FDA Class III initiated 21 Nov 2012
    • Terminated Z-0638-2013 FDA Class III initiated 21 Nov 2012

    When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).

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  • Withdrawn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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