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510(k) K831735

MAPROTILINE by Utak Laboratories, Inc. — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
May 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Utak Laboratories, Inc.

  • K903061 — UTAK LABORATORIES TOXICOLOGY CONTROL (April 12, 1991)
  • K883147 — TRACE ELEMENTS SERUM TOXICOLOGY CONTROL (October 6, 1988)
  • K862419 — SERUM VANCOMYCIN TOXICOLOGY CONTROL (November 13, 1986)
  • K862418 — BENZODIAZEPINES TOXICOLOGY CONTROL (November 13, 1986)
  • K862421 — SERUM CLONAZEPAM TOXICOLOGY CONTROL (November 5, 1986)
  • K862420 — UTAK-STABBS TOXICOLOGY CONTROL (August 4, 1986)
  • K831736 — TRICYCLIC ANTIDEPRESSANTS (July 28, 1983)
  • K831741 — FLURAZEPAM TOXICOLOGY CONTROL (July 26, 1983)
  • K831738 — CAFFINE TOXICOLOGY CONTROL (July 26, 1983)
  • K831734 — AMOXAPINE 8-HYDRO-XYAMOXAPINE (July 26, 1983)

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