Kodak Ektachem Clinical Chem. NH3

• • Terminated Z-0297-2014 FDA Class II ·initiated 12 Jun 2013

  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

510(k) Number

K820723 ↗

FDA Product Code

JID

Device Class

Class I

Regulation

21 CFR Part 862.1065

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

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• Kodak X-Omat 3000 Ra Processor

  Class II

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  FDA 510(k) K934350 Active Cleared 21 Mar 1994

• Amerlite Prolactin-30 Assay

  Class I

  FDA 510(k) K922170 Active Cleared 2 Sep 1992

• Trophypan C with Orthoimaging/Omsimaging Accessory

  Class II

  FDA 510(k) K040556 Active Cleared 7 Apr 2004

See all devices from Eastman Kodak Company →