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510(k) K012131

LIVESURE BENZODIAZEPINES SCREEN TESTS by Pan Probe Biotech, Inc. — Product Code JXM

K012131 is an FDA 510(k) premarket notification submitted by Pan Probe Biotech, Inc. for the device "LIVESURE BENZODIAZEPINES SCREEN TESTS". The FDA issued a decision of Substantially Equivalent on July 20, 2001. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Pan Probe Biotech, Inc. has at least 9 other 510(k) clearances on record.

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, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
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)
  • K012133 — LIVESURE BARBITURATES SCREEN TEST (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)

Other clearances for product code JXM

  • K243498 — Alinity c Benzodiazepines Reagent Kit (December 11, 2024)
  • K221765 — ONLINE DAT Benzodiazepines II (December 23, 2022)
  • K190968 — CEDIA Benzodiazepine Assay (December 9, 2019)
  • K173963 — DRI Benzodiazepine Assay (February 21, 2018)
  • K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair (September 15, 2017)
  • K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (August 2, 2017)
  • K153597 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 23, 2016)
  • K151771 — Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (January 5, 2016)
  • K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (August 13, 2015)
  • K150356 — Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (May 13, 2015)

FDA data resources