Quantase Total Galactose Screening Assay 500 Test Kit

• • Terminated Z-1562-2011 FDA Unclassified (pre-2012) ·initiated 26 Jan 2010 ·on shared 510(k) K990654

  Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K990654 ↗

FDA Product Code

JIA

FDA applicant

Quantase , Ltd.

Device Class

Class I

Regulation

21 CFR Part 862.1310

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Quantase Phe/Gal Screening Assay

  Class II

  FDA 510(k) K984463 Active Cleared 16 Feb 1999

• Quantase Total Galactose Screening Assay

  Class I

  FDA 510(k) K990644 Active Cleared 21 Jun 1999

• Quantase Phenylalanine Screening Assay 500 Test Kit

  Class II

  FDA 510(k) K000754 Active Cleared 19 Jun 2000