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510(k) K972331

INNOFLUOR GENTAMICIN ASSAY SYSTEM by Oxis Intl., Inc. — Product Code LGQ

K972331 is an FDA 510(k) premarket notification submitted by Oxis Intl., Inc. for the device "INNOFLUOR GENTAMICIN ASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 1, 1997. The device falls under product code LGQ (Fluorescence Polarization Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Oxis Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1997
Date Received
June 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

Other clearances by Oxis Intl., Inc.

  • K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (July 14, 1997)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K970509 — INNOFLOUR CALIBRATOR REAGENT SET (May 12, 1997)
  • K970510 — INNOFLOUR TOPIRAMATE REAGENT 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 LGQ

  • K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (July 14, 1997)
  • K940596 — AXSYM PHENOBARBITAL (June 21, 1994)
  • K936130 — COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (March 11, 1994)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K894525 — FPR PHENOBARBITAL KIT (August 28, 1989)
  • K872397 — COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. (July 21, 1987)
  • K863625 — PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT (November 10, 1986)
  • K862528 — IMMPULSE PHENOBARBITAL ASSAY REAGENTS (July 16, 1986)
  • K854044 — TDX BARBITURATES (October 28, 1985)
  • K843825 — COBAS REAGENTS PHENOBARBITAL & PHENOBAR (February 1, 1985)

FDA data resources