Resolve-Hb

• • Terminated Z-0047-05 FDA Unclassified (pre-2012) ·initiated 14 Sep 2004

  The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component. The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored at 2-30 degrees C.

• • Terminated Z-1158-04 FDA Unclassified (pre-2012) ·initiated 29 Jun 2004 ·via K840011, on the same 510(k)

  Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.

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

510(k) Number

K840011 ↗

FDA Product Code

GKA

Device Class

Class II

Regulation

21 CFR Part 864.7415

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hdl-Cholesterol Control Serum

  Class I

  FDA 510(k) K802997 Active Cleared 22 Dec 1980

• Sickle Hb Assay

  Class II

  FDA 510(k) K841170 Active Cleared 4 Apr 1984

• Hemocard(Tm) Control

  Class II

  FDA 510(k) K924173 Active Cleared 1 Dec 1992

• Isolab's T4 Test Kit

  Class II

  FDA 510(k) K951014 Active Cleared 18 Oct 1996

• Scalpel

  Class I

  FDA 510(k) K780998 Active Cleared 27 Jul 1978

• Visible-Chlamydia(Tm) Test System

  Class I

  FDA 510(k) K862638 Active Cleared 26 Aug 1986

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