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510(k) K942610

KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) by Eastman Kodak Company — Product Code LFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
June 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Digitoxin
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
Submission Type

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Other clearances for product code LFM

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  • K963158 — ABBOTT AXSYM DIGITOXIN (MODIFY) (September 10, 1996)
  • K954420 — AXSYM DIGITOXIN (December 29, 1995)
  • K951631 — DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (June 9, 1995)
  • K943235 — IMMULITE DIGITOXIN (October 27, 1994)
  • K942619 — EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (September 20, 1994)
  • K915465 — DIGITOXIN FPIA REAGENT SET (January 27, 1992)