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510(k) K935629

USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 by U.S. Drug Testing, Inc. — Product Code LCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1994
Date Received
November 23, 1993
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 U.S. Drug Testing, Inc.

  • K940912 — USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 (June 2, 1994)
  • K934693 — AMPHETAMINE TEST SYSTEM (November 22, 1993)
  • K932318 — USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 (June 15, 1993)
  • K931227 — USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 (May 6, 1993)
  • K930985 — USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 (April 27, 1993)

Other clearances for product code LCM

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  • 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)