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510(k) K970509

INNOFLOUR CALIBRATOR REAGENT SET by Oxis Intl., Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1997
Date Received
February 11, 1997
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 Oxis Intl., Inc.

  • K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (August 1, 1997)
  • K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (July 14, 1997)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K970510 — INNOFLOUR TOPIRAMATE REAGENT SET (May 12, 1997)
  • K955568 — INNOFLUOR QUINIDINE ASSAY SYSTEM (April 4, 1996)
  • K955569 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (February 9, 1996)
  • K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM (February 9, 1996)
  • K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (January 24, 1996)
  • K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEM (January 24, 1996)
  • K950346 — B-L RED(TM) DISCS (May 5, 1995)

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