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510(k) K060896

MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT by Varian, Inc. — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2006
Date Received
April 3, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Varian, Inc.

  • K051235 — ON TRAK TESTCARD (June 8, 2005)
  • K050321 — ONTRAK TESTCARD 9 (April 18, 2005)
  • 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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  • K031497 — AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST (October 17, 2003)