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510(k) K912755

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE by Roche Diagnostic Systems, Inc. — Product Code DJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
June 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Roche Diagnostic Systems, Inc.

  • K983698 — MODIFICATION TO ABUSCREEN ONLINE BARBITURATES (May 3, 1999)
  • K983702 — MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES (February 11, 1999)
  • K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (February 10, 1999)
  • K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS (December 15, 1998)
  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
  • K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (December 11, 1998)
  • K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (December 11, 1998)
  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
  • K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (December 11, 1998)

Other clearances for product code DJP

  • K960526 — PRIMIDONE EIA TEST (March 18, 1996)
  • K913866 — URINE AMPHETAMINE DIRECT RIA KIT (I-125) (September 25, 1991)
  • K882228 — REVISED DOUBLE ANTIBODY AMPHETAMINE (August 8, 1988)
  • K881817 — ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES (July 29, 1988)
  • K854009 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP (October 15, 1985)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K823212 — ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE (November 29, 1982)
  • K812986 — AGGLUTEX AMPHETAMINE TEST KIT (January 22, 1982)