Smart Alex Compact Clinical Analyzer(Cca)(Filter P

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K850995 ↗

FDA Product Code

JJQ

Device Class

Class I

Regulation

21 CFR Part 862.2300

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Focus-Ghb

  Class II

  FDA 510(k) K871679 Active Cleared 28 Jul 1987

• Smart Alex Ii Multi-Filter Photometer

  Class I

  FDA 510(k) K850993 Active Cleared 7 May 1985

• Chemwell, Also Known As Project 2900

  Class II

  FDA 510(k) K013420 Active Cleared 19 Jul 2002

• Hemoglobin Analyzer

  Class II

  FDA 510(k) K851467 Active Cleared 16 Jul 1985

• Stat Fax(Tm)

  Class I

  FDA 510(k) K882938 Active Cleared 9 Sep 1988

• Spectra 1 Filter Photometer

  Class I

  FDA 510(k) K850994 Active Cleared 10 May 1985

See all devices from Awareness Technology, Inc. →