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510(k) K955444

ABBOTT AXSM PROCAINAMIDE ASSAY by Abbott Laboratories — Product Code LAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1996
Date Received
November 28, 1995
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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  • K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY (August 14, 1996)
  • K951434 — OPUS PROCAINAMIDE (July 3, 1995)
  • K942847 — COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (December 2, 1994)
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