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510(k) K913198

KODAK EKTACHEM DT SLIDES (CHE) by Eastman Kodak Company — Product Code DIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
July 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Cholinesterase
Device Class
Class I
Regulation Number
862.3240
Review Panel
TX
Submission Type

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Other clearances for product code DIH

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  • K013750 — ADVIA 1650 CHOLINESTERASE ASSAY (January 18, 2002)
  • K002792 — CARESIDE CHOLINESTERASE (November 8, 2000)
  • K001344 — ADVIA IMS (June 26, 2000)
  • K961656 — TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (November 26, 1996)
  • K943367 — IL TEST CHOLINESTERASE (February 5, 1996)