Sta System Control [N] + [P] Kit

• • Terminated Z-0738-2020 FDA Class II ·initiated 18 Nov 2019

  A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

• • Terminated Z-1044-2012 FDA Unclassified (pre-2012) ·initiated 23 Aug 2011

  Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.

510(k) Number

K943518 ↗

FDA Product Code

GGN

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →