Allgrad and ALLGRAD100

• • Terminated Z-3029-2020 FDA Class II ·initiated 18 Aug 2020 ·via K022335, on the same 510(k)

  Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

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

510(k) Number

K022335 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• <genx> Single Lumen Sideport Needle

  Class II

  FDA 510(k) K991264 Active Cleared 9 Sep 1999

• Genxcatheter

  Class II

  FDA 510(k) K963031 Active Cleared 21 Oct 1996

• Global by <genx> Blastocyst Media

  Class II

  FDA 510(k) K010183 Active Cleared 2 May 2001

• Allgrad Wash (Herpes Buffered Washing Medium)

  Class II

  FDA 510(k) K023033 Active Cleared 26 Nov 2002

• Htf Plus - Htf with Non-Essential Amino Acids

  Class II

  FDA 510(k) K022334 Active Cleared 28 Aug 2002

• Genx Microtools

  Class II

  FDA 510(k) K993884 Active Cleared 14 Feb 2000

See all devices from <Genx> Intl., Inc. →