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510(k) K911153

MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT by Immunotech Corp. — Product Code LCM

K911153 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT". The FDA issued a decision of Substantially Equivalent on June 18, 1991. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Immunotech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1991
Date Received
March 15, 1991
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 Immunotech Corp.

  • K954188 — OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL (November 3, 1995)
  • K946335 — OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES (October 20, 1995)
  • K953498 — OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL (September 8, 1995)
  • K952789 — OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES (August 14, 1995)
  • K952182 — OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES (July 5, 1995)
  • K950626 — OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES (May 5, 1995)
  • K934012 — FT4 RADIOIMMUNOASSAY (November 16, 1993)
  • K931228 — PROGESTERONE RADIOIMMUNOASSAY KIT (October 22, 1993)
  • K911634 — MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST (June 24, 1991)
  • K910411 — MICROZYME TSH ENZYME IMMUNOASSAY KIT (April 3, 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