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510(k) K970509

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

K970509 is an FDA 510(k) premarket notification submitted by Oxis Intl., Inc. for the device "INNOFLOUR CALIBRATOR REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 12, 1997. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Oxis Intl., Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances for product code DLJ

  • K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPIN (August 8, 2013)
  • K091617 — QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (July 17, 2009)
  • K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (August 22, 2008)
  • K062182 — DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (September 14, 2006)
  • K062199 — DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (September 6, 2006)
  • K061503 — DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (June 22, 2006)
  • K060503 — DIMENSION TACR CALIBRATOR, MODEL DC107 (May 18, 2006)
  • 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)

FDA data resources