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510(k) K830481

ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE by Hoffmann-La Roche, Inc. — Product Code LCL

K830481 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code LCL (Radioimmunoassay, Phencyclidine), a Class U device. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
February 15, 1983
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 Hoffmann-La Roche, Inc.

  • K850727 — BHCG-ROCHE EIA (June 25, 1985)
  • K831694 — RENAK (July 19, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823580 — COBAS REAGENT FOR INORGANIC PHOSPHORUS (January 7, 1983)
  • K823576 — COBAS STANDARD FOR TOTAL PROTEIN (January 7, 1983)

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

FDA data resources