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510(k) K062229

CTC WORKSTATION, MODEL 2200 by Medical Diagnostic Technologies, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2006
Date Received
August 2, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Medical Diagnostic Technologies, Inc.

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  • K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (August 14, 1996)
  • K962489 — CHROMOLIZE TPA ASSAY KIT (July 31, 1996)
  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K955738 — BIOCLOT PROTEIN S (February 29, 1996)
  • K952746 — ALKALINE PHOSPHATASE REAGENT SYSTEM (November 27, 1995)

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