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510(k) K834464

TDX PROCAINAMIDE by Abbott Laboratories — Product Code LAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1984
Date Received
December 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Procainamide
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

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Other clearances for product code LAR

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  • K955444 — ABBOTT AXSM PROCAINAMIDE ASSAY (April 2, 1996)
  • K951434 — OPUS PROCAINAMIDE (July 3, 1995)
  • K942847 — COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (December 2, 1994)