Variant Nbs Sickle Cell Program Reagent Kit, Variant Nbs Newborn Screening System and Variant Nbs Workstation with

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K080911 ↗

FDA Product Code

GKA

Device Class

Class II

Regulation

21 CFR Part 864.7415

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Variant II Turbo Link Hemoglobin A1C Program, and Variant II Turbo Link Hemoglobin Testing with Model, 270-2716,

  Class II

  FDA 510(k) K070819 Active Cleared 25 Jun 2007

• Variant II Turbo HBA1C Kit-2.0 Variant II Turbo Hemoglobin Testing System

  Class II

  FDA 510(k) K122472 Active Cleared 26 Oct 2012

• Variant(Tm) II Turbo HBA1C Kit - 2.0

  Class II

  FDA 510(k) K130990 Active Cleared 9 May 2013

• Modification to Variant II: Hemoglobin A1C Program, Beta-Thalassemia Short Program and Total Ghb Program

  Class II

  FDA 510(k) K063643 Active Cleared 27 Dec 2006

• Variant II Hemoglobin A1C Program (New), Variant II Hemoglobin Testing System with Cdm Software, Cdm Software

  Class II

  FDA 510(k) K130860 Active Cleared 25 Apr 2013