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510(k) K033601

LABONE MICRO-PLATE COTININE EIA by Labone, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2004
Date Received
November 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Labone, Inc.

  • K040198 — LABONE COCAINE METABOLITE MICRO-PLATE EIA (March 5, 2004)

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  • K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (September 12, 2005)
  • K033246 — PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS (December 2, 2003)