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510(k) K903061

UTAK LABORATORIES TOXICOLOGY CONTROL by Utak Laboratories, Inc. — Product Code LAS

K903061 is an FDA 510(k) premarket notification submitted by Utak Laboratories, Inc. for the device "UTAK LABORATORIES TOXICOLOGY CONTROL". The FDA issued a decision of Substantially Equivalent on April 12, 1991. The device falls under product code LAS (Drug Specific 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
April 12, 1991
Date Received
July 9, 1990
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.

  • K883147 — TRACE ELEMENTS SERUM TOXICOLOGY CONTROL (October 6, 1988)
  • K862418 — BENZODIAZEPINES TOXICOLOGY CONTROL (November 13, 1986)
  • K862419 — SERUM VANCOMYCIN 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)
  • K831735 — MAPROTILINE (July 26, 1983)
  • K831734 — AMOXAPINE 8-HYDRO-XYAMOXAPINE (July 26, 1983)
  • K831741 — FLURAZEPAM TOXICOLOGY CONTROL (July 26, 1983)

Other clearances for product code LAS

  • K080459 — CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (November 17, 2009)
  • K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (January 30, 2008)
  • K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL (October 30, 2006)
  • K051074 — MAS IMMUNOSUPPRESSANT CONTROLS (June 6, 2005)
  • K040411 — DRI OXYCODONE ASSAY (May 27, 2004)
  • K032842 — MICROGENICS CYCLOSPORINE CONTROL KIT (October 17, 2003)
  • K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (March 31, 2003)
  • K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (July 14, 1999)
  • K970517 — INNOFLUOR TOPIRAMATE CONTROL SET (May 12, 1997)
  • K971210 — SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS (April 17, 1997)

FDA data resources