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510(k) K913187

INNOFLUOR(TM) DIGITOXIN REAGENT SET by Intl. Bioclinical, Inc. — Product Code LFM

K913187 is an FDA 510(k) premarket notification submitted by Intl. Bioclinical, Inc. for the device "INNOFLUOR(TM) DIGITOXIN REAGENT SET". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code LFM (Enzyme Immunoassay, Digitoxin), a Class II device regulated under 21 CFR 862.3300. Intl. Bioclinical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
July 18, 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 Intl. Bioclinical, Inc.

  • K913186 — INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET (August 30, 1991)
  • K911688 — INNOFLUOR(TM) VALPROIC ACID REAGENT SET (July 5, 1991)
  • K911466 — INNOFLUOR VALPROIC ACID CALIBRATOR SET (May 23, 1991)
  • K883533 — ABC FP ANALYZER (December 15, 1988)
  • K864156 — PROGESTERONE SYSTEM BY EIA (November 24, 1986)

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