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510(k) K922991

ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE by Abbott Laboratories — Product Code LGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1992
Date Received
June 22, 1992
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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  • K932127 — TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (August 9, 1993)
  • 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)