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510(k) K032564

DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 by Dade Behring, Inc. — Product Code LAN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2003
Date Received
August 20, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, N-Acetylprocainamide
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

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  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code LAN

  • K060738 — TDM N-ACETYLPROCAINAMIDE (August 16, 2006)
  • K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 (June 18, 2001)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (June 11, 1997)
  • K955422 — AXSYM N-ACETYLPROCAINAMIDE (April 24, 1996)
  • K934705 — OPUS NAPA (November 22, 1993)
  • K922915 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT (August 24, 1992)
  • K895571 — N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT (October 25, 1989)
  • K873349 — EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 (September 22, 1987)
  • K871680 — MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR (June 8, 1987)