Actin, Activated Cephaloplastin Reagent

• • Terminated Z-1703-2015 FDA Class II ·initiated 25 Mar 2015

  Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range.

510(k) Number

K760318 ↗

FDA Product Code

GFO

Device Class

Class II

Regulation

21 CFR Part 864.7925

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Whole Blood Gas Control, Levels 1, 2, &3

  Class II

  FDA 510(k) K800296 Active Cleared 5 Mar 1980

• Immu-Sal Immunohematological Saline

  Class I

  FDA 510(k) K761303 Active Cleared 30 Dec 1976

• Immu-Tek Automatic Centrifuge

  Class II

  FDA 510(k) K790767 Active Cleared 23 May 1979

• Heparin Assay

  Class II

  FDA 510(k) K781479 Active Cleared 15 Feb 1979

• Ferritin Radioimmunoassay

  Class II

  FDA 510(k) K792442 Active Cleared 18 Dec 1979

• Isozyme - Id Cpk Marker

  Class I

  FDA 510(k) K780801 Active Cleared 13 Jun 1978

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