Dsl Active Ifgbp-3 Elisa

• • Terminated Z-2184-2011 FDA Unclassified (pre-2012) ·initiated 30 Mar 2011

  The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).

510(k) Number

K951707 ↗

FDA Product Code

CFL

Device Class

Class I

Regulation

21 CFR Part 862.1370

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Dsl Active Shbg (Dsl 7400)

  Class I

  FDA 510(k) K915823 Active Cleared 17 Mar 1992

• Active T3 Ria

  Class II

  FDA 510(k) K960550 Active Cleared 6 Mar 1996

• Dsl Beta 2 Microglobulin (Dsl 6200)

  Class II

  FDA 510(k) K911881 Active Cleared 10 Sep 1991

• Active Crosslaps Elisa

  Class I

  FDA 510(k) K960171 Active Cleared 28 Mar 1996

• Dsl Aactive Dhea Eia Kit

  Class I

  FDA 510(k) K955114 Active Cleared 23 Feb 1996

• Dsl Insulin Ria (Dsl 1600)

  Class I

  FDA 510(k) K914820 Active Cleared 9 Jan 1992

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