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510(k) K812986

AGGLUTEX AMPHETAMINE TEST KIT by Hoffmann-La Roche, Inc. — Product Code DJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1982
Date Received
October 26, 1981
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 Hoffmann-La Roche, Inc.

  • K850727 — BHCG-ROCHE EIA (June 25, 1985)
  • K831694 — RENAK (July 19, 1983)
  • K830461 — ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE (March 24, 1983)
  • K830462 — ABUSCREEN RADIOUMMUNOASSAY--URINE (March 24, 1983)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K830481 — ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE (March 24, 1983)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)
  • K830480 — ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (March 24, 1983)
  • K830479 — ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (March 10, 1983)
  • K823578 — COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (January 7, 1983)

Other clearances for product code DJP

  • K960526 — PRIMIDONE EIA TEST (March 18, 1996)
  • K913866 — URINE AMPHETAMINE DIRECT RIA KIT (I-125) (September 25, 1991)
  • K912755 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE (August 26, 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)