Home / 510(k) Clearances / K944605

510(k) K944605

CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM by Beckman-Diagnostic Systems Group — Product Code LCM

K944605 is an FDA 510(k) premarket notification submitted by Beckman-Diagnostic Systems Group for the device "CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM". The FDA issued a decision of Substantially Equivalent on December 7, 1994. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Beckman-Diagnostic Systems Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1994
Date Received
September 19, 1994
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 Beckman-Diagnostic Systems Group

  • K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (December 12, 1994)
  • K944604 — CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS (December 7, 1994)
  • K944606 — CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS (November 30, 1994)
  • K942676 — SYNCHRON CX3 DELTA (November 2, 1994)
  • K934293 — BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT (July 6, 1994)
  • K934068 — BECKMAN DIRECT BILIRUBIN REAGENT (April 26, 1994)
  • K936184 — VIGIL PRX CHEMISTRY CONTROL (April 15, 1994)
  • K934271 — BECKMAN SYNCHRON LACTATE REAGENT (November 9, 1993)
  • K934046 — BECKMAN CHOLESTEROL REAGENT (October 28, 1993)
  • K934467 — BECKMAN CX AMMONIA/ALCOHOL CONTROL (October 27, 1993)

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