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510(k) K981292

QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST by Syntron Bioresearch, Inc. — Product Code LCM

K981292 is an FDA 510(k) premarket notification submitted by Syntron Bioresearch, Inc. for the device "QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST". The FDA issued a decision of Substantially Equivalent on May 26, 1998. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Syntron Bioresearch, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1998
Date Received
April 9, 1998
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 Syntron Bioresearch, Inc.

  • K993491 — QUICKPAC II ONE STEP OPIATES TEST (October 29, 1999)
  • K993490 — QUICKSTRIP ONE STEP OPIATES TEST (October 29, 1999)
  • K992990 — QUICKPAC II ONE STEP COCAINE TEST (September 20, 1999)
  • K992748 — DRUGCHECK X MULTIDRUG SCREENING DEVICE (September 2, 1999)
  • K992207 — QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM (July 22, 1999)
  • K990325 — QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE (June 24, 1999)
  • K983113 — BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (November 18, 1998)
  • K981019 — QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST (May 7, 1998)
  • K980349 — QUICKPAC II ONE STEP BARBITURATE TEST (March 3, 1998)
  • K974712 — QUIKSTRIP ONE STEP BARBITURATE TEST (February 12, 1998)

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