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510(k) K955567

INNOFLUOR THEOPHYLLINE ASSAY SYSTEM by Oxis Intl., Inc. — Product Code LGS

K955567 is an FDA 510(k) premarket notification submitted by Oxis Intl., Inc. for the device "INNOFLUOR THEOPHYLLINE ASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 24, 1996. The device falls under product code LGS (Fluorescence Polarization Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Oxis Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1996
Date Received
December 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
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)
  • 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)
  • K950346 — B-L RED(TM) DISCS (May 5, 1995)

Other clearances for product code LGS

  • K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (June 8, 2007)
  • K953016 — AXSYM THEOPHYLLINE II (August 24, 1995)
  • K951169 — CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY (June 20, 1995)
  • K942991 — QMS THEOPHYLLINE CS (September 9, 1994)
  • K932127 — TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (August 9, 1993)
  • K922991 — ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE (August 27, 1992)
  • K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (April 12, 1990)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K871484 — COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (May 28, 1987)
  • K870277 — MONITORX LASERX THEOPHYLLINE REAGENT SET (February 18, 1987)

FDA data resources