Home / 510(k) Clearances / K991505

510(k) K991505

MICRO-STRIP FOR PHENCYCLIDINE METABOLITES by Microdiagnostics, Inc. — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1999
Date Received
April 29, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

Other clearances by Microdiagnostics, Inc.

  • K011952 — DRUGS OF ABUSE MULTI-TEST STRIP (October 25, 2001)
  • K991516 — MICRO-STRIP FOR MARIJUANA METABOLITES (August 5, 1999)
  • K981388 — MICRO-STRIP FOR COCAINE METABOLITES (May 29, 1998)
  • K974611 — MICRO-STRIP FOR AMPHETAMINE METABOLITES (March 20, 1998)
  • K973761 — MICRO-STRIP FOR OPIATE METABOLITES (December 24, 1997)
  • K932304 — MICRO EIA FOR AMPHETAMINE METABOLITES (December 7, 1993)
  • K923468 — MICRO EIA FOR OPIATE METABOLITES (September 15, 1992)
  • K914533 — MICRO EIA FOR COCAINE METABOLITES (December 10, 1991)
  • K914490 — MICRO EIA FOR MARIJUANA METABOLITES (November 29, 1991)

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)