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510(k) K012133

LIVESURE BARBITURATES SCREEN TEST by Pan Probe Biotech, Inc. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2001
Date Received
July 9, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
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)
  • K011610 — LIVESURE METHAMPHETAMINE SCREEN TESTS (June 8, 2001)
  • K011609 — LIVESURE AMPHETAMINE SCREEN TEST (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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  • K092268 — RANDOX BARITURATES ASSAY (May 25, 2011)
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  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
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