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510(k) K042725

QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) by Quest Diagnostics, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2005
Date Received
October 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Quest Diagnostics, Inc.

  • K080381 — QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA (June 25, 2008)
  • K062929 — QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA (December 18, 2006)
  • K051161 — QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES) (November 22, 2005)
  • K042726 — QUEST DIAGNOSTICS HAIRCHECK-DT (PCP (July 28, 2005)
  • K040257 — QUEST DIAGNOSTICS HAIRCHECK-DT (THC) (June 14, 2004)
  • K023626 — AML HAIRCHECK-DT (COCAINE) (September 29, 2003)

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