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510(k) K163220

Atellica CH Phencyclidine (Pcp) by Siemens Healthcare Diagnostics, Inc. — Product Code LCM

K163220 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Atellica CH Phencyclidine (Pcp)". The FDA issued a decision of Substantially Equivalent on April 6, 2017. The device falls under product code LCM (Enzyme Immunoassay, Phencyclidine), a Class U device. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2017
Date Received
November 16, 2016
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 Siemens Healthcare Diagnostics, Inc.

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (February 27, 2026)
  • K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) (February 6, 2026)
  • K251630 — Atellica IM Total PSA II (tPSAII) (January 5, 2026)
  • K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (December 4, 2025)
  • K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II (October 17, 2025)
  • K242981 — Atellica IM Thyroglobulin (Tg) (June 20, 2025)
  • K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens (April 25, 2025)
  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)

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

FDA data resources