Resolve-Csf

• • Terminated Z-0973-03 FDA Unclassified (pre-2012) ·initiated 16 May 2002 ·via K843122, on the same 510(k)

  The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.

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

510(k) Number

K843122 ↗

FDA Product Code

DFI

Device Class

Class I

Regulation

21 CFR Part 866.5860

Advisory Committee

Immunology

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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