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510(k) K874484

REVISED LABELING FOR TDX PHENCYCLIDINE by Abbott Laboratories — Product Code LCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1987
Date Received
October 30, 1987
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

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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)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K800514 — PHENCYCLIDINE DIRECT BLOOD RIA KIT (March 19, 1980)
  • K790655 — ABUSCREEN RIA FOR PHENCYCLIDINE (June 15, 1979)