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510(k) K831734

AMOXAPINE 8-HYDRO-XYAMOXAPINE by Utak Laboratories, Inc. — Product Code DIF

K831734 is an FDA 510(k) premarket notification submitted by Utak Laboratories, Inc. for the device "AMOXAPINE 8-HYDRO-XYAMOXAPINE". The FDA issued a decision of Substantially Equivalent on July 26, 1983. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Utak Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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 Mixture 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)
  • K831738 — CAFFINE TOXICOLOGY CONTROL (July 26, 1983)
  • K831741 — FLURAZEPAM TOXICOLOGY CONTROL (July 26, 1983)
  • K831735 — MAPROTILINE (July 26, 1983)

Other clearances for product code DIF

  • K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, (February 23, 2016)
  • K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/N (December 16, 2013)
  • K132174 — MULTICHEM WBT (September 20, 2013)
  • K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (July 3, 2012)
  • K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (May 18, 2012)
  • K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOG (March 27, 2012)
  • K103656 — THERMO SCIENTIFIC MAS R DOA TOTAL (March 24, 2011)
  • K093577 — LIQUICHEK OPIATE CONTROL (March 12, 2010)
  • K080085 — MAS TOX CONTROL (April 30, 2008)
  • K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMI (March 25, 2008)

FDA data resources