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510(k) K883147

TRACE ELEMENTS SERUM TOXICOLOGY CONTROL by Utak Laboratories, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1988
Date Received
July 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Utak Laboratories, Inc.

  • K903061 — UTAK LABORATORIES TOXICOLOGY CONTROL (April 12, 1991)
  • 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)
  • K831735 — MAPROTILINE (July 26, 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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