Reporting Integrator 3392A

• • Terminated Z-0324-04 FDA Unclassified (pre-2012) ·initiated 17 Nov 2003 ·via K833113, on the same 510(k)

  Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.

• • Terminated Z-0690-03 FDA Unclassified (pre-2012) ·initiated 11 Dec 2002 ·via K833113, on the same 510(k)

  Unexpected false positive TCA results

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

510(k) Number

K833113 ↗

FDA Product Code

LDM

Device Class

Class I

Regulation

21 CFR Part 862.2260

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Luer Lock Skirt

  Class II

  FDA 510(k) K862451 Active Cleared 31 Oct 1986

• Hp Sonos 100 Cf Ultrasound Imaging System

  Class II

  FDA 510(k) K922184 Active Cleared 30 Jul 1992

• Medical Diag. Ultrasound Instr. 77065

  Class II

  FDA 510(k) K842897 Active Cleared 25 Sep 1984

• Model M1403A Telemetry Monitoring Systems (TMS)

  Class II

  FDA 510(k) K913533 Active Cleared 7 Nov 1991

• Differential Refractive Index Detector

  Class I

  FDA 510(k) K800556 Active Cleared 25 Mar 1980

• Model 80100A, Patient Data Memory

  Class II

  FDA 510(k) K781360 Active Cleared 7 Sep 1978

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