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510(k) K883147

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

K883147 is an FDA 510(k) premarket notification submitted by Utak Laboratories, Inc. for the device "TRACE ELEMENTS SERUM TOXICOLOGY CONTROL". The FDA issued a decision of Substantially Equivalent on October 6, 1988. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Utak Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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)
  • 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)
  • K831741 — FLURAZEPAM TOXICOLOGY CONTROL (July 26, 1983)
  • K831735 — MAPROTILINE (July 26, 1983)
  • K831734 — AMOXAPINE 8-HYDRO-XYAMOXAPINE (July 26, 1983)
  • K831738 — CAFFINE TOXICOLOGY CONTROL (July 26, 1983)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources