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510(k) K011275

PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY by Psychemedics Corp. — Product Code LCL

K011275 is an FDA 510(k) premarket notification submitted by Psychemedics Corp. for the device "PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY". The FDA issued a decision of Substantially Equivalent on February 11, 2002. The device falls under product code LCL (Radioimmunoassay, Phencyclidine), a Class U device. Psychemedics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2002
Date Received
April 26, 2001
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 Psychemedics Corp.

  • K130811 — PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE (May 2, 2013)
  • K123799 — PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR (February 8, 2013)
  • K111927 — PSYCHEMEDICS METHAMPHETAMINE EIA (May 1, 2012)
  • K111926 — PSYCHEMEDICS OPIATES EIA (May 1, 2012)
  • K111925 — PSYCHEMEDICS COCAINE EIA (May 1, 2012)
  • K111929 — PSYCHEMEDICS CANNABINOIDS EIA (May 1, 2012)
  • K111928 — PSYCHEMEDICS PHENCYCLIDINE EIA (May 1, 2012)
  • K011426 — PSYCHEMEDICS RIA CANNABINOID ASSAY (May 3, 2002)
  • K011185 — PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY (January 24, 2002)
  • K010868 — PSYCHEMEDICS RIA COCAINE ASSAY (November 6, 2001)

Other clearances for product code LCL

  • 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)
  • K800514 — PHENCYCLIDINE DIRECT BLOOD RIA KIT (March 19, 1980)
  • K790655 — ABUSCREEN RIA FOR PHENCYCLIDINE (June 15, 1979)

FDA data resources