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510(k) K060773

ONLINE TDM PROCAINAMIDE by Roche Diagnostics Corp. — Product Code LAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2006
Date Received
March 22, 2006
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

  • 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)
  • K934762 — OPUS PROCAINAMIDE TEST SYSTEM (July 20, 1994)