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510(k) K913240

DIGITOXIN (FPIA) KIT by Tudor Laboratories, Inc. — Product Code LFM

K913240 is an FDA 510(k) premarket notification submitted by Tudor Laboratories, Inc. for the device "DIGITOXIN (FPIA) KIT". The FDA issued a decision of Substantially Equivalent on September 6, 1991. The device falls under product code LFM (Enzyme Immunoassay, Digitoxin), a Class II device regulated under 21 CFR 862.3300. Tudor Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1991
Date Received
July 22, 1991
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 Tudor Laboratories, Inc.

  • K921904 — THYROXINE (FPIA) KIT (June 24, 1992)
  • K921903 — THYROXINE CALIBRATOR KIT (May 26, 1992)
  • K895572 — N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT (October 30, 1989)
  • K895571 — N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT (October 25, 1989)
  • K895567 — PRIMIDONE (FPIA) KIT (October 20, 1989)
  • K895569 — VALPROIC ACID (FPIA) KIT (October 3, 1989)
  • K895570 — VALPROIC ACID (FPIA) CALIBRATOR KIT (September 28, 1989)
  • K895568 — PRIMIDONE (FPIA) CALIBRATOR KIT (September 28, 1989)

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)
  • K942610 — KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) (October 20, 1994)
  • K942619 — EMIT 2000 DIGOXIN ASSAY/CALIBRATORS (September 20, 1994)

FDA data resources