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510(k) K791551

HI-M-TEST MORPHINE by Technam, Inc. — Product Code DLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1979
Date Received
August 14, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemagglutination Inhibition, Morphine
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type

Other clearances by Technam, Inc.

  • K801509 — HI-M-TEST FOR METHADONE TEST #2 (July 14, 1980)
  • K800055 — H-I-M-TEST FOR DETECTING HUMAN CHOR. GON (January 29, 1980)

Other clearances for product code DLR

  • K760074 — KIT, MORPHINE (TOXI-PAK IMMUNO HI) (July 20, 1976)