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510(k) K834464

TDX PROCAINAMIDE by Abbott Laboratories — Product Code LAR

K834464 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX PROCAINAMIDE". The FDA issued a decision of Substantially Equivalent on February 3, 1984. The device falls under product code LAR (Enzyme Immunoassay, Procainamide), a Class II device regulated under 21 CFR 862.3320. Abbott Laboratories has at least 10 other 510(k) clearances on record.

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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  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

Other clearances for product code LAR

  • K060773 — ONLINE TDM PROCAINAMIDE (August 23, 2006)
  • K032573 — DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 (October 31, 2003)
  • K010812 — EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 (April 13, 2001)
  • K971716 — PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (June 27, 1997)
  • K963306 — CEDIA N-ACETYLPROCAINAMIDE ASSAY (October 29, 1996)
  • K962099 — CEDIA PROCAINAMIDE ASSAY (August 27, 1996)
  • K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY (August 14, 1996)
  • 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)

FDA data resources