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No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K011130 ↗

FDA Product Code

ELM

Device Class

Class II

Regulation

21 CFR Part 872.3590

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Clinistat Glucose Reagent Test

  Class II

  FDA 510(k) K884756 Active Cleared 13 Jan 1989

• Herador Ec, Pf, C, H, Nh, G, Gg and Mp; Heraloy U and G; Herabond N; Albabond C, B and a; Bio Heranorm

  Class II

  FDA 510(k) K034049 Active Cleared 1 Mar 2004

• Ames Dca 2000TM Analyzer and Reagent System

  Class II

  FDA 510(k) K911625 Active Cleared 5 Sep 1991

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

  Class I

  FDA 510(k) K943780 Active Cleared 31 Oct 1994

• Flexitime Xtreme

  Class II

  FDA 510(k) K042878 Active Cleared 17 Dec 2004

• Venus Diamond Flow

  Class II

  FDA 510(k) K091635 Active Cleared 3 Sep 2009

See all devices from Heraeus Kulzer, Inc. →