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510(k) K962099

CEDIA PROCAINAMIDE ASSAY by Boehringer Mannheim Corp. — Product Code LAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1996
Date Received
May 29, 1996
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

Other clearances by Boehringer Mannheim Corp.

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  • K983047 — ACCU-CHEK HQ SYSTEM (February 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (February 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (January 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K983510 — CHEMSTRIP 101 URINE ANALYZER (October 27, 1998)

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)
  • 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)