Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample

• • Terminated Z-1139-03 FDA Unclassified (pre-2012) ·initiated 27 Jun 2003 ·on shared 510(k) K950803

  The kits are producing lower values than expected, which may result in an increase of false positive test results.

• • Terminated Z-0898-03 FDA Unclassified (pre-2012) ·initiated 8 Jan 2003

  The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K950803 ↗

FDA Product Code

JJT

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hdl-Cholesterol Control Serum

  Class I

  FDA 510(k) K802997 Active Cleared 22 Dec 1980

• Resolve-Hb

  Class II

  FDA 510(k) K840011 Active Cleared 4 Feb 1984

• 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

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