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510(k) K012107

LIVESURE PHENECYCLINE (PCP) SCREEN TESTS by Pan Probe Biotech, Inc. — Product Code LCM

K012107 is an FDA 510(k) premarket notification submitted by Pan Probe Biotech, Inc. for the device "LIVESURE PHENECYCLINE (PCP) SCREEN TESTS". The FDA issued a decision of Substantially Equivalent on July 20, 2001. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. 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 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Enzyme Immunoassay, Phencyclidine
Device Class
Class U
Regulation Number
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)
  • K012133 — LIVESURE BARBITURATES SCREEN TEST (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 LCM

  • K212952 — Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (April 18, 2022)
  • K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay (April 20, 2021)
  • K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (January 24, 2019)
  • K163220 — Atellica CH Phencyclidine (Pcp) (April 6, 2017)
  • K152176 — Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (September 4, 2015)
  • K142044 — CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE (August 25, 2014)
  • K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (June 25, 2013)
  • K122703 — RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAP (April 25, 2013)
  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)

FDA data resources