Neonatal Chemistry System, Galactose Test Kit

• 5 recalls, same reason

  • Terminated Z-0514-04 FDA Unclassified (pre-2012) ·initiated 9 Jan 2004
  • Terminated Z-0515-04 FDA Unclassified (pre-2012) ·initiated 9 Jan 2004
  • Terminated Z-0969-03 FDA Unclassified (pre-2012) ·initiated 30 May 2003
  • Terminated Z-0970-03 FDA Unclassified (pre-2012) ·initiated 30 May 2003
  • Terminated Z-0971-03 FDA Unclassified (pre-2012) ·initiated 30 May 2003

  The device is not stable throughout its labeled expiration date.

510(k) Number

K950481 ↗

FDA Product Code

JIA

Device Class

Class I

Regulation

21 CFR Part 862.1310

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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