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510(k) K033659

VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK by Varian, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2004
Date Received
November 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Varian, Inc.

  • K060896 — MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT (June 9, 2006)
  • K051235 — ON TRAK TESTCARD (June 8, 2005)
  • K050321 — ONTRAK TESTCARD 9 (April 18, 2005)
  • K033902 — ONTRAK TESTCUP II AND ONSITE CUPKIT (January 20, 2004)

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