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510(k) K911466

INNOFLUOR VALPROIC ACID CALIBRATOR SET by Intl. Bioclinical, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1991
Date Received
April 3, 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)
  • K913186 — INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET (August 30, 1991)
  • K911688 — INNOFLUOR(TM) VALPROIC ACID REAGENT SET (July 5, 1991)
  • K883533 — ABC FP ANALYZER (December 15, 1988)
  • K864156 — PROGESTERONE SYSTEM BY EIA (November 24, 1986)

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