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510(k) K955444

ABBOTT AXSM PROCAINAMIDE ASSAY by Abbott Laboratories — Product Code LAR

K955444 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT AXSM PROCAINAMIDE ASSAY". The FDA issued a decision of Substantially Equivalent on April 2, 1996. 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
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

  • 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)
  • K951434 — OPUS PROCAINAMIDE (July 3, 1995)
  • K942847 — COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (December 2, 1994)
  • K934762 — OPUS PROCAINAMIDE TEST SYSTEM (July 20, 1994)

FDA data resources