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510(k) K163629

Audit MicroControls Linearity FD Tumor Markers II by Aalto Scientific, Ltd. — Product Code JJY

K163629 is an FDA 510(k) premarket notification submitted by Aalto Scientific, Ltd. for the device "Audit MicroControls Linearity FD Tumor Markers II". The FDA issued a decision of Substantially Equivalent on March 10, 2017. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Aalto Scientific, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2017
Date Received
December 22, 2016
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 Aalto Scientific, Ltd.

  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K143571 — Audit MicroControls Linearity LQ Cystatin-C (January 23, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K143026 — Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity (November 21, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)
  • K130762 — AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET (April 29, 2013)
  • K130764 — AUDIT MICROCV VITAMIN D LINEARITY SET (April 26, 2013)
  • K130157 — AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET (March 19, 2013)
  • K112742 — AUDIT MICROLQ SPINAL FLUID CONTROL (June 15, 2012)
  • K111964 — AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY (March 2, 2012)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 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)
  • K133676 — ABX PENTRA MICRO ALB CONTROL L/H (July 11, 2014)

FDA data resources