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510(k) K011609

LIVESURE AMPHETAMINE SCREEN TEST by Pan Probe Biotech, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2001
Date Received
May 25, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Pan Probe Biotech, Inc.

  • K020968 — LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD (July 15, 2002)
  • K013796 — LIVESURE METHADONE SCREEN TESTS (November 26, 2001)
  • K012131 — LIVESURE BENZODIAZEPINES SCREEN TESTS (July 20, 2001)
  • K012107 — LIVESURE PHENECYCLINE (PCP) SCREEN TESTS (July 20, 2001)
  • K012133 — LIVESURE BARBITURATES SCREEN TEST (July 20, 2001)
  • K011610 — LIVESURE METHAMPHETAMINE SCREEN TESTS (June 8, 2001)
  • K010967 — LIVESURE COCAINE SCREEN TEST (April 17, 2001)
  • K011011 — LIVESURE MORPHINE SCREEN TEST (April 13, 2001)
  • K010001 — LIVESURE THC SCREEN TEST (February 5, 2001)

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