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510(k) K800514

PHENCYCLIDINE DIRECT BLOOD RIA KIT by Immunalysis Corporation — Product Code LCL

K800514 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "PHENCYCLIDINE DIRECT BLOOD RIA KIT". The FDA issued a decision of Substantially Equivalent on March 19, 1980. The device falls under product code LCL (Radioimmunoassay, Phencyclidine), a Class U device. Immunalysis Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1980
Date Received
March 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Phencyclidine
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

Other clearances by Immunalysis Corporation

  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K232898 — Quantisal™ Oral Fluid Collection Device (November 21, 2023)
  • K223781 — Quantisal™ II Oral Fluid Collection Device (July 28, 2023)
  • K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay (April 20, 2021)
  • K200801 — Quantisal Oral Fluid Collection Device (July 28, 2020)
  • K190397 — Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (November 15, 2019)
  • K183048 — Quantisal II Oral Fluid Collection Device (July 29, 2019)
  • K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (January 24, 2019)

Other clearances for product code LCL

  • K011275 — PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY (February 11, 2002)
  • K994093 — AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C (December 16, 1999)
  • K913864 — PCP DIRECT RIA KIT (I-125) (October 11, 1991)
  • K890882 — ABUSCREEN FP FOR PHENCYCLIDINE (March 15, 1989)
  • K882179 — EMIT HVA PHENCYCLIDINE ASSAY (July 12, 1988)
  • K880011 — REVISED LABELING FOR ADX PHENCYCLIDINE (February 11, 1988)
  • K874626 — REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS (January 11, 1988)
  • K874484 — REVISED LABELING FOR TDX PHENCYCLIDINE (November 23, 1987)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K790655 — ABUSCREEN RIA FOR PHENCYCLIDINE (June 15, 1979)

FDA data resources