Inview

• • Terminated Z-0289-2008 FDA Unclassified (pre-2012) ·initiated 31 Aug 2007

  Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.

510(k) Number

K051321 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Osteomark Ntx Poc

  Class I

  FDA 510(k) K992997 Active Cleared 9 Nov 1999

• A1CNOW for Home and Professional Use

  Class II

  FDA 510(k) K033847 Active Cleared 23 Dec 2003

• A1CNOW for Professional Use

  Class II

  FDA 510(k) K020235 Active Cleared 15 Feb 2002

• Drx Qt. Hcg

  Class II

  FDA 510(k) K991532 Active Cleared 17 Sep 1999

• Osteomark Ntx Point of Care (Poc) Control Set

  Class I

  FDA 510(k) K991917 Active Cleared 12 Jul 1999

• Drx HBA1C - For Prescription Home Use

  Class II

  FDA 510(k) K000885 Active Cleared 26 Sep 2000

See all devices from Metrika, Inc. →