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510(k) K040257

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2004
Date Received
February 4, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
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)
  • K042725 — QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) (July 6, 2005)
  • K023626 — AML HAIRCHECK-DT (COCAINE) (September 29, 2003)

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