Clinitek 50 Urine Chemistry Analyzer

• • Terminated Z-1051-04 FDA Unclassified (pre-2012) ·initiated 12 Mar 2004

  Some units may only have had 1 read head screw installed instead of the three required by the firm's specifications.

• • Terminated Z-0911-03 FDA Unclassified (pre-2012) ·initiated 19 Jun 2003 ·on shared 510(k) K960546

  Analyzer will produce erroneous results due to missing grounding strap.

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

510(k) Number

K960546 ↗

FDA Product Code

KQO

Device Class

Class I

Regulation

21 CFR Part 862.2900

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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