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510(k) K801509

HI-M-TEST FOR METHADONE TEST #2 by Technam, Inc. — Product Code DIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1980
Date Received
June 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemagglutination Inhibition, Methadone
Device Class
Class II
Regulation Number
862.3620
Review Panel
TX
Submission Type

Other clearances by Technam, Inc.

  • K800055 — H-I-M-TEST FOR DETECTING HUMAN CHOR. GON (January 29, 1980)
  • K791551 — HI-M-TEST MORPHINE (October 17, 1979)

Other clearances for product code DIW

  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)
  • K930845 — ROCHE ABUSCREEN ONTRAK FOR METHADONE (April 20, 1993)
  • K760075 — KIT, METHADONE (TOXI-PAK IMMUNO HI) (July 20, 1976)