Refobacin -Palacos G

• • Terminated Z-0730-2014 FDA Class II ·initiated 4 Nov 2013 ·via K031673, on the same 510(k)

  The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K031673 ↗

FDA Product Code

LOD

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

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. →