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510(k) K820391

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI by Hoffmann-La Roche, Inc. — Product Code LAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1982
Date Received
February 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cannabinoid(S)
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

Other clearances by Hoffmann-La Roche, Inc.

  • K850727 — BHCG-ROCHE EIA (June 25, 1985)
  • K831694 — RENAK (July 19, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823575 — COBAS STANDARDS FOR ALBUMIN (January 7, 1983)

Other clearances for product code LAT

  • K011426 — PSYCHEMEDICS RIA CANNABINOID ASSAY (May 3, 2002)
  • K961620 — ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (June 13, 1996)
  • K936135 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRAT (June 10, 1996)
  • K914507 — DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE (December 18, 1991)
  • K913414 — ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT (September 25, 1991)
  • K913865 — URINE THC DIRECT RIA KIT (I-125) (September 18, 1991)
  • K912574 — ABUSCREEN ONLINE FOR THC (50 AND 100) (August 12, 1991)
  • K904996 — ABUSCREEN ONLINE TM FOR THC (January 11, 1991)
  • K843534 — ORAL THC-CANNABINOIDS DIRECT RIA KIT (October 30, 1984)
  • K833911 — URINE THC CANNABINOIDS DIRECT RIA KIT (January 24, 1984)