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510(k) K913186

INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET by Intl. Bioclinical, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1991
Date Received
July 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Intl. Bioclinical, Inc.

  • K913187 — INNOFLUOR(TM) DIGITOXIN REAGENT SET (September 23, 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)

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  • K053108 — DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (February 16, 2006)
  • K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (September 12, 2005)
  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)