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510(k) K932127

TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II by Abbott Laboratories — Product Code LGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1993
Date Received
May 3, 1993
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

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Other clearances for product code LGS

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  • K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (January 24, 1996)
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  • 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)