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510(k) K921651

MICROLINE SCREEN FOR PHENCYCLIDINE by Drug Screening Systems, Inc. — Product Code LCM

K921651 is an FDA 510(k) premarket notification submitted by Drug Screening Systems, Inc. for the device "MICROLINE SCREEN FOR PHENCYCLIDINE". The FDA issued a decision of Substantially Equivalent on July 8, 1992. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Drug Screening Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1992
Date Received
April 6, 1992
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 Drug Screening Systems, Inc.

  • K945829 — MICROLINE SCREEN FOR BENZODIAZEPINE (January 25, 1995)
  • K935052 — MICROLINE SCREEN FOR AMPHETAMINE (September 16, 1994)
  • K933480 — MICROLINE SCREEN FOR BARBITURATES (October 29, 1993)
  • K914915 — MICROLINE SCREEN FOR CANNABINOID (January 22, 1992)
  • K911652 — MIRCOLINE SCREEN FOR COCAINE (May 15, 1991)
  • K910525 — MICROLINE SCREEN FOR METHAMPHETAMINE (April 5, 1991)
  • K905491 — MICROLINE SCREEN FOR OPIATES (March 13, 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)

FDA data resources