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510(k) K942610

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

K942610 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)". The FDA issued a decision of Substantially Equivalent on October 20, 1994. The device falls under product code LFM (Enzyme Immunoassay, Digitoxin), a Class II device regulated under 21 CFR 862.3300. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

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

Other clearances by Eastman Kodak Company

  • K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 (March 31, 2006)
  • K060137 — KODAK ECLIPSE IMAGE PROCESSING SOFTWARE (March 16, 2006)
  • K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM (February 8, 2006)
  • K060055 — KODAK PACS (February 7, 2006)
  • K053347 — KODAK CARESTREAM PACS (January 4, 2006)
  • K051483 — KODAK DIRECTVIEW DR SYSTEM DETECTOR (June 21, 2005)
  • K051258 — KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 (June 1, 2005)
  • K042158 — KODAK MEDICAL IMAGER 300 (September 24, 2004)
  • K042159 — KODAK COLOR MEDICAL IMAGER 1000 (September 24, 2004)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)

Other clearances for product code LFM

  • K062024 — DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, (July 28, 2006)
  • K012112 — RANDOX DIGITOXIN (January 11, 2002)
  • 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)
  • 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)

FDA data resources