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510(k) K131181

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE by Omega Laboratories, Inc. — Product Code LCM

K131181 is an FDA 510(k) premarket notification submitted by Omega Laboratories, Inc. for the device "OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE". The FDA issued a decision of Substantially Equivalent on June 25, 2013. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Omega Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2013
Date Received
April 25, 2013
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 Omega Laboratories, Inc.

  • K142855 — Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-me (July 28, 2015)
  • K140671 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCOD (January 8, 2015)
  • K131128 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (November 13, 2013)
  • K122759 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) (December 5, 2012)
  • K112808 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (January 23, 2012)
  • K103161 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES (December 13, 2011)
  • K101973 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENE (August 16, 2011)
  • K101059 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE (July 12, 2010)

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)
  • 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)
  • K093989 — ORAL FLUID PHENCYCLIDINE (January 25, 2011)

FDA data resources