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510(k) K972330

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 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

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  • K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEM (January 24, 1996)
  • K950346 — B-L RED(TM) DISCS (May 5, 1995)

Other clearances for product code LGQ

  • K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (August 1, 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)