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510(k) K051235

ON TRAK TESTCARD by Varian, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2005
Date Received
May 13, 2005
Clearance Type
Special
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

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  • K033902 — ONTRAK TESTCUP II AND ONSITE CUPKIT (January 20, 2004)
  • K033659 — VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK (January 6, 2004)

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