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510(k) K951631

DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS by Bayer Corp. — Product Code LFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1995
Date Received
April 7, 1995
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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  • K990251 — DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 (March 31, 1999)
  • K970546 — ACS DIGITOXIN (July 14, 1997)
  • K963158 — ABBOTT AXSYM DIGITOXIN (MODIFY) (September 10, 1996)
  • K954420 — AXSYM DIGITOXIN (December 29, 1995)
  • K943235 — IMMULITE DIGITOXIN (October 27, 1994)
  • K942610 — KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) (October 20, 1994)
  • K942619 — EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (September 20, 1994)
  • K915465 — DIGITOXIN FPIA REAGENT SET (January 27, 1992)