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510(k) K955568

INNOFLUOR QUINIDINE ASSAY SYSTEM by Oxis Intl., Inc. — Product Code LBZ

K955568 is an FDA 510(k) premarket notification submitted by Oxis Intl., Inc. for the device "INNOFLUOR QUINIDINE ASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 4, 1996. The device falls under product code LBZ (Enzyme Immunoassay, Quinidine), a Class II device regulated under 21 CFR 862.3320. Oxis Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1996
Date Received
December 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Quinidine
Device Class
Class II
Regulation Number
862.3320
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)
  • K970509 — INNOFLOUR CALIBRATOR REAGENT SET (May 12, 1997)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • 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 LBZ

  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K032332 — ROCHE ONLINE TDM QUINIDINE (January 12, 2004)
  • K011605 — EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (June 12, 2001)
  • K964116 — QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (December 24, 1996)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K941440 — COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS (July 6, 1994)
  • K922913 — EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS (August 24, 1992)
  • K904990 — EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS (February 4, 1991)
  • K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (April 12, 1990)
  • K892208 — INNOFLUOR(TM) QUINIDINE REAGENT SET (June 9, 1989)

FDA data resources